Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen)

NCT03943602 | Unknown Phase 2

• 1 other identifier: CaboPen
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Cabozantinib in patients with advanced penile squamous cell carcinoma (PSCC): an open-label, single-center, phase 2, single-arm trial (CaboPen)

Conditions

Penile Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• response -rate by RECIST v1.1 criteria

  Assessment of response-rate by RECIST v1.1. Complete response + partial response

  40 months

Secondary Outcomes (6)

• Incidence of treatment-Emergent Adverse Event(safety and tolerability)

  40 months

• Pathologic complete response (pCR)

  40 months

• Progression-free survival (PFS).

  40 months

• Overall Survival (OS).

  40 months

• Variations of the Quality of Life

  40 months

Study Arms (1)

Cabozantinib

EXPERIMENTAL

Cabozantinib will be administered orally at a dose of 60 mg/day continuously until 28 days prior to planned surgery or at time of the evidence of disease progression or onset of unacceptable toxicity.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Cabozantinib 60 mg/day orally

Also known as: CABOMETYX

Cabozantinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Written informed consent
• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• Cytologically or histologically proven diagnosis of PSCC.
• Histologically (Tru-cut biopsy) proven diagnosis of loco-regional nodal disease will be required in all cases except for those with clinical contraindications.
• Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria.
• Clinical stage N2-3 and/or M1 (TNM 2002).
• Locoregional relapse after prior major surgery/ies (either single or multiple).
• No prior systemic therapy except for the administration of VBM (Vinblastine, Bleomycin, Methotrexate) chemotherapy for superficial disease if administered at least 6 months prior to study enrolment.
• Adequate organ and marrow function .
• Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study. Patients registered on this trial must be treated and followed at the study sponsor site.

You may not qualify if:

• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting.
• Myocardial infarction.
• Unstable angina.
• Coronary artery by-pass graft surgery.
• Symptomatic peripheral vascular disease.
• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
• Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted during the study but should be used with caution - please refer to the study drug IB).
• Screening ECG with a QTc\>450 msec, congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate \< 50 bpm (patients with a pacemaker and heart rate \> 50 bpm are eligible).
• Uncontrolled hypertension.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months ior to first dose of study drug.
• History of HIV infection or active chronic hepatitis B or C.
• Active clinically serious infections (\> grade 2 NCI-CTC version 5.0).
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
• Patients undergoing renal dialysis

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (64)

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

  PMID: 22237781 BACKGROUND

• Barnholtz-Sloan JS, Maldonado JL, Pow-sang J, Giuliano AR. Incidence trends in primary malignant penile cancer. Urol Oncol. 2007 Sep-Oct;25(5):361-7. doi: 10.1016/j.urolonc.2006.08.029.

  PMID: 17826651 BACKGROUND

• Ornellas AA. Management of penile cancer. J Surg Oncol. 2008 Mar 1;97(3):199-200. doi: 10.1002/jso.20893. No abstract available.

  PMID: 17918225 BACKGROUND

• Misra S, Chaturvedi A, Misra NC. Penile carcinoma: a challenge for the developing world. Lancet Oncol. 2004 Apr;5(4):240-7. doi: 10.1016/S1470-2045(04)01427-5.

  PMID: 15050955 BACKGROUND

• Heideman DA, Waterboer T, Pawlita M, Delis-van Diemen P, Nindl I, Leijte JA, Bonfrer JM, Horenblas S, Meijer CJ, Snijders PJ. Human papillomavirus-16 is the predominant type etiologically involved in penile squamous cell carcinoma. J Clin Oncol. 2007 Oct 10;25(29):4550-6. doi: 10.1200/JCO.2007.12.3182.

  PMID: 17925550 BACKGROUND

• Li D, Han Z, Liu J, Zhang X, Ren J, Yan L, Liu H, Xu Z. Upregulation of nucleus HDGF predicts poor prognostic outcome in patients with penile squamous cell carcinoma bypass VEGF-A and Ki-67. Med Oncol. 2013 Dec;30(4):702. doi: 10.1007/s12032-013-0702-9. Epub 2013 Sep 3.

  PMID: 23999841 BACKGROUND

• Zhu Y, Li H, Yao XD, Zhang SL, Zhang HL, Shi GH, Yang LF, Yang ZY, Wang CF, Ye DW. Feasibility and activity of sorafenib and sunitinib in advanced penile cancer: a preliminary report. Urol Int. 2010;85(3):334-40. doi: 10.1159/000315432. Epub 2010 Oct 27.

  PMID: 20980789 BACKGROUND

• Bleeker MC, Heideman DA, Snijders PJ, Horenblas S, Dillner J, Meijer CJ. Penile cancer: epidemiology, pathogenesis and prevention. World J Urol. 2009 Apr;27(2):141-50. doi: 10.1007/s00345-008-0302-z. Epub 2008 Jul 8.

  PMID: 18607597 BACKGROUND

• Bezerra AL, Lopes A, Santiago GH, Ribeiro KC, Latorre MR, Villa LL. Human papillomavirus as a prognostic factor in carcinoma of the penis: analysis of 82 patients treated with amputation and bilateral lymphadenectomy. Cancer. 2001 Jun 15;91(12):2315-21.

  PMID: 11413520 BACKGROUND

• Backes DM, Kurman RJ, Pimenta JM, Smith JS. Systematic review of human papillomavirus prevalence in invasive penile cancer. Cancer Causes Control. 2009 May;20(4):449-57. doi: 10.1007/s10552-008-9276-9. Epub 2008 Dec 11.

  PMID: 19082746 BACKGROUND

• Gregoire L, Cubilla AL, Reuter VE, Haas GP, Lancaster WD. Preferential association of human papillomavirus with high-grade histologic variants of penile-invasive squamous cell carcinoma. J Natl Cancer Inst. 1995 Nov 15;87(22):1705-9. doi: 10.1093/jnci/87.22.1705.

  PMID: 7473819 BACKGROUND

• Miralles-Guri C, Bruni L, Cubilla AL, Castellsague X, Bosch FX, de Sanjose S. Human papillomavirus prevalence and type distribution in penile carcinoma. J Clin Pathol. 2009 Oct;62(10):870-8. doi: 10.1136/jcp.2008.063149. Epub 2009 Aug 25.

  PMID: 19706632 BACKGROUND

• Rubin MA, Kleter B, Zhou M, Ayala G, Cubilla AL, Quint WG, Pirog EC. Detection and typing of human papillomavirus DNA in penile carcinoma: evidence for multiple independent pathways of penile carcinogenesis. Am J Pathol. 2001 Oct;159(4):1211-8. doi: 10.1016/S0002-9440(10)62506-0.

  PMID: 11583947 BACKGROUND

• Mannweiler S, Sygulla S, Beham-Schmid C, Razmara Y, Pummer K, Regauer S. Penile carcinogenesis in a low-incidence area: a clinicopathologic and molecular analysis of 115 invasive carcinomas with special emphasis on chronic inflammatory skin diseases. Am J Surg Pathol. 2011 Jul;35(7):998-1006. doi: 10.1097/PAS.0b013e3182147e59.

  PMID: 21681144 BACKGROUND

• Castellsague X, Bosch FX, Munoz N, Meijer CJ, Shah KV, de Sanjose S, Eluf-Neto J, Ngelangel CA, Chichareon S, Smith JS, Herrero R, Moreno V, Franceschi S; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners. N Engl J Med. 2002 Apr 11;346(15):1105-12. doi: 10.1056/NEJMoa011688.

  PMID: 11948269 BACKGROUND

• Backes DM, Bleeker MC, Meijer CJ, Hudgens MG, Agot K, Bailey RC, Ndinya-Achola JO, Hayombe J, Hogewoning CJ, Moses S, Snijders PJ, Smith JS. Male circumcision is associated with a lower prevalence of human papillomavirus-associated penile lesions among Kenyan men. Int J Cancer. 2012 Apr 15;130(8):1888-97. doi: 10.1002/ijc.26196. Epub 2011 Aug 2.

  PMID: 21618520 BACKGROUND

• Barroso LF 2nd, Wilkin T. Human papillomavirus vaccination in males: the state of the science. Curr Infect Dis Rep. 2011 Apr;13(2):175-81. doi: 10.1007/s11908-010-0163-7.

  PMID: 21365381 BACKGROUND

• Engels EA, Pfeiffer RM, Goedert JJ, Virgo P, McNeel TS, Scoppa SM, Biggar RJ; HIV/AIDS Cancer Match Study. Trends in cancer risk among people with AIDS in the United States 1980-2002. AIDS. 2006 Aug 1;20(12):1645-54. doi: 10.1097/01.aids.0000238411.75324.59.

  PMID: 16868446 BACKGROUND

• Daling JR, Madeleine MM, Johnson LG, Schwartz SM, Shera KA, Wurscher MA, Carter JJ, Porter PL, Galloway DA, McDougall JK, Krieger JN. Penile cancer: importance of circumcision, human papillomavirus and smoking in in situ and invasive disease. Int J Cancer. 2005 Sep 10;116(4):606-16. doi: 10.1002/ijc.21009.

  PMID: 15825185 BACKGROUND

• Hellberg D, Valentin J, Eklund T, Nilsson S. Penile cancer: is there an epidemiological role for smoking and sexual behaviour? Br Med J (Clin Res Ed). 1987 Nov 21;295(6609):1306-8. doi: 10.1136/bmj.295.6609.1306.

  PMID: 3120988 BACKGROUND

• Marconnet L, Rigaud J, Bouchot O. Long-term followup of penile carcinoma with high risk for lymph node invasion treated with inguinal lymphadenectomy. J Urol. 2010 Jun;183(6):2227-32. doi: 10.1016/j.juro.2010.02.025.

  PMID: 20399455 BACKGROUND

• Protzel C, Alcaraz A, Horenblas S, Pizzocaro G, Zlotta A, Hakenberg OW. Lymphadenectomy in the surgical management of penile cancer. Eur Urol. 2009 May;55(5):1075-88. doi: 10.1016/j.eururo.2009.02.021. Epub 2009 Feb 23.

  PMID: 19264390 BACKGROUND

• Heyns CF, Fleshner N, Sangar V, Schlenker B, Yuvaraja TB, van Poppel H. Management of the lymph nodes in penile cancer. Urology. 2010 Aug;76(2 Suppl 1):S43-57. doi: 10.1016/j.urology.2010.03.001.

  PMID: 20691885 BACKGROUND

• Pompeo AC. Extended lymphadenectomy in penile cancer. Can J Urol. 2005 Feb;12 Suppl 1:30-6; discussion 97-8.

  PMID: 15780162 BACKGROUND

• Kroon BK, Horenblas S, Lont AP, Tanis PJ, Gallee MP, Nieweg OE. Patients with penile carcinoma benefit from immediate resection of clinically occult lymph node metastases. J Urol. 2005 Mar;173(3):816-9. doi: 10.1097/01.ju.0000154565.37397.4d.

  PMID: 15711276 BACKGROUND

• Lont AP, Kroon BK, Gallee MP, van Tinteren H, Moonen LM, Horenblas S. Pelvic lymph node dissection for penile carcinoma: extent of inguinal lymph node involvement as an indicator for pelvic lymph node involvement and survival. J Urol. 2007 Mar;177(3):947-52; discussion 952. doi: 10.1016/j.juro.2006.10.060.

  PMID: 17296384 BACKGROUND

• Ornellas AA, Kinchin EW, Nobrega BL, Wisnescky A, Koifman N, Quirino R. Surgical treatment of invasive squamous cell carcinoma of the penis: Brazilian National Cancer Institute long-term experience. J Surg Oncol. 2008 May 1;97(6):487-95. doi: 10.1002/jso.20980.

  PMID: 18425779 BACKGROUND

• Spiess PE, Izawa JI, Bassett R, Kedar D, Busby JE, Wong F, Eddings T, Tamboli P, Pettaway CA. Preoperative lymphoscintigraphy and dynamic sentinel node biopsy for staging penile cancer: results with pathological correlation. J Urol. 2007 Jun;177(6):2157-61. doi: 10.1016/j.juro.2007.01.125.

  PMID: 17509308 BACKGROUND

• Izawa J, Kedar D, Wong F, Pettaway CA. Sentinel lymph node biopsy in penile cancer: evolution and insights. Can J Urol. 2005 Feb;12 Suppl 1:24-9.

  PMID: 15780161 BACKGROUND

• Hungerhuber E, Schlenker B, Frimberger D, Linke R, Karl A, Stief CG, Schneede P. Lymphoscintigraphy in penile cancer: limited value of sentinel node biopsy in patients with clinically suspicious lymph nodes. World J Urol. 2006 Aug;24(3):319-24. doi: 10.1007/s00345-006-0073-3. Epub 2006 Apr 11.

  PMID: 16688459 BACKGROUND

• Neto AS, Tobias-Machado M, Ficarra V, Wroclawski ML, Amarante RD, Pompeo AC, Del Giglio A. Dynamic sentinel node biopsy for inguinal lymph node staging in patients with penile cancer: a systematic review and cumulative analysis of the literature. Ann Surg Oncol. 2011 Jul;18(7):2026-34. doi: 10.1245/s10434-010-1546-6. Epub 2011 Feb 10.

  PMID: 21308487 BACKGROUND

• Graafland NM, Valdes Olmos RA, Meinhardt W, Bex A, van der Poel HG, van Boven HH, Nieweg OE, Horenblas S. Nodal staging in penile carcinoma by dynamic sentinel node biopsy after previous therapeutic primary tumour resection. Eur Urol. 2010 Nov;58(5):748-51. doi: 10.1016/j.eururo.2010.06.036. Epub 2010 Jul 12.

  PMID: 20633981 BACKGROUND

• Pettaway CA, Pisters LL, Dinney CP, Jularbal F, Swanson DA, von Eschenbach AC, Ayala A. Sentinel lymph node dissection for penile carcinoma: the M. D. Anderson Cancer Center experience. J Urol. 1995 Dec;154(6):1999-2003.

  PMID: 7500444 BACKGROUND

• Pizzocaro G, Algaba F, Horenblas S, Solsona E, Tana S, Van Der Poel H, Watkin NA; European Association of Urology (EAU) Guidelines Group on Penile Cancer. EAU penile cancer guidelines 2009. Eur Urol. 2010 Jun;57(6):1002-12. doi: 10.1016/j.eururo.2010.01.039. Epub 2010 Feb 4.

  PMID: 20163910 BACKGROUND

• Gagliano RG, Blumenstein BA, Crawford ED, Stephens RL, Coltman CA Jr, Costanzi JJ. cis-Diamminedichloroplatinum in the treatment of advanced epidermoid carcinoma of the penis: a Southwest Oncology Group Study. J Urol. 1989 Jan;141(1):66-7. doi: 10.1016/s0022-5347(17)40590-8.

  PMID: 2642312 BACKGROUND

• Leijte JA, Kirrander P, Antonini N, Windahl T, Horenblas S. Recurrence patterns of squamous cell carcinoma of the penis: recommendations for follow-up based on a two-centre analysis of 700 patients. Eur Urol. 2008 Jul;54(1):161-8. doi: 10.1016/j.eururo.2008.04.016. Epub 2008 Apr 15.

  PMID: 18440124 BACKGROUND

• Culkin DJ, Beer TM. Advanced penile carcinoma. J Urol. 2003 Aug;170(2 Pt 1):359-65. doi: 10.1097/01.ju.0000062829.43654.5e.

  PMID: 12853775 BACKGROUND

• Pizzocaro G, Piva L. Adjuvant and neoadjuvant vincristine, bleomycin, and methotrexate for inguinal metastases from squamous cell carcinoma of the penis. Acta Oncol. 1988;27(6b):823-4. doi: 10.3109/02841868809094366.

  PMID: 2466471 BACKGROUND

• Leijte JA, Kerst JM, Bais E, Antonini N, Horenblas S. Neoadjuvant chemotherapy in advanced penile carcinoma. Eur Urol. 2007 Aug;52(2):488-94. doi: 10.1016/j.eururo.2007.02.006. Epub 2007 Feb 14.

  PMID: 17316964 BACKGROUND

• Hakenberg OW, Nippgen JB, Froehner M, Zastrow S, Wirth MP. Cisplatin, methotrexate and bleomycin for treating advanced penile carcinoma. BJU Int. 2006 Dec;98(6):1225-7. doi: 10.1111/j.1464-410X.2006.06496.x.

  PMID: 17125480 BACKGROUND

• Bermejo C, Busby JE, Spiess PE, Heller L, Pagliaro LC, Pettaway CA. Neoadjuvant chemotherapy followed by aggressive surgical consolidation for metastatic penile squamous cell carcinoma. J Urol. 2007 Apr;177(4):1335-8. doi: 10.1016/j.juro.2006.11.038.

  PMID: 17382727 BACKGROUND

• Pagliaro LC, Williams DL, Daliani D, Williams MB, Osai W, Kincaid M, Wen S, Thall PF, Pettaway CA. Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. J Clin Oncol. 2010 Aug 20;28(24):3851-7. doi: 10.1200/JCO.2010.29.5477. Epub 2010 Jul 12.

  PMID: 20625118 BACKGROUND

• Graafland NM, Valdes Olmos RA, Teertstra HJ, Kerst JM, Bergman AM, Horenblas S. 18F-FDG PET/CT for monitoring induction chemotherapy in patients with primary inoperable penile carcinoma: first clinical results. Eur J Nucl Med Mol Imaging. 2010 Aug;37(8):1474-80. doi: 10.1007/s00259-010-1434-0. Epub 2010 Mar 27.

  PMID: 20349185 BACKGROUND

• Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

  PMID: 17960012 BACKGROUND

• Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

  PMID: 17960013 BACKGROUND

• Hitt R, Lopez-Pousa A, Martinez-Trufero J, Escrig V, Carles J, Rizo A, Isla D, Vega ME, Marti JL, Lobo F, Pastor P, Valenti V, Belon J, Sanchez MA, Chaib C, Pallares C, Anton A, Cervantes A, Paz-Ares L, Cortes-Funes H. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005 Dec 1;23(34):8636-45. doi: 10.1200/JCO.2004.00.1990. Epub 2005 Nov 7.

  PMID: 16275937 BACKGROUND

• Maiche AG. Adjuvant treatment using bleomycin in squamous cell carcinoma of penis: study of 19 cases. Br J Urol. 1983 Oct;55(5):542-4. doi: 10.1111/j.1464-410x.1983.tb03366.x.

  PMID: 6194844 BACKGROUND

• Protzel C, Ruppin S, Milerski S, Klebingat KJ, Hakenberg OW. [The current state of the art of chemotherapy of penile cancer: results of a nationwide survey of German clinics]. Urologe A. 2009 Dec;48(12):1495-8. doi: 10.1007/s00120-009-2108-z. German.

  PMID: 19774356 BACKGROUND

• Corral DA, Sella A, Pettaway CA, Amato RJ, Jones DM, Ellerhorst J. Combination chemotherapy for metastatic or locally advanced genitourinary squamous cell carcinoma: a phase II study of methotrexate, cisplatin and bleomycin. J Urol. 1998 Nov;160(5):1770-4.

  PMID: 9783949 BACKGROUND

• Dexeus FH, Logothetis CJ, Sella A, Amato R, Kilbourn R, Fitz K, Striegel A. Combination chemotherapy with methotrexate, bleomycin and cisplatin for advanced squamous cell carcinoma of the male genital tract. J Urol. 1991 Nov;146(5):1284-7. doi: 10.1016/s0022-5347(17)38069-2.

  PMID: 1719241 BACKGROUND

• Haas GP, Blumenstein BA, Gagliano RG, Russell CA, Rivkin SE, Culkin DJ, Wolf M, Crawford ED. Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: a Southwest Oncology Group study. J Urol. 1999 Jun;161(6):1823-5.

  PMID: 10332445 BACKGROUND

• Pettaway CA, Pagliaro L, Theodore C, Haas G. Treatment of visceral, unresectable, or bulky/unresectable regional metastases of penile cancer. Urology. 2010 Aug;76(2 Suppl 1):S58-65. doi: 10.1016/j.urology.2010.03.082.

  PMID: 20691886 BACKGROUND

• Pizzocaro G, Nicolai N, Milani A. Taxanes in combination with cisplatin and fluorouracil for advanced penile cancer: preliminary results. Eur Urol. 2009 Mar;55(3):546-51. doi: 10.1016/j.eururo.2008.07.014. Epub 2008 Jul 14.

  PMID: 18649992 BACKGROUND

• Trabulsi EJ, Hoffman-Censits J. Chemotherapy for penile and urethral carcinoma. Urol Clin North Am. 2010 Aug;37(3):467-74. doi: 10.1016/j.ucl.2010.04.010.

  PMID: 20674701 BACKGROUND

• Hussein AM, Benedetto P, Sridhar KS. Chemotherapy with cisplatin and 5-fluorouracil for penile and urethral squamous cell carcinomas. Cancer. 1990 Feb 1;65(3):433-8. doi: 10.1002/1097-0142(19900201)65:33.0.co;2-g.

  PMID: 2297633 BACKGROUND

• Shammas FV, Ous S, Fossa SD. Cisplatin and 5-fluorouracil in advanced cancer of the penis. J Urol. 1992 Mar;147(3):630-2. doi: 10.1016/s0022-5347(17)37327-5.

  PMID: 1538445 BACKGROUND

• Di Lorenzo G, Buonerba C, Federico P, Perdona S, Aieta M, Rescigno P, D'Aniello C, Puglia L, Petremolo A, Ferro M, Marinelli A, Palmieri G, Sonpavde G, Mirone V, De Placido S. Cisplatin and 5-fluorouracil in inoperable, stage IV squamous cell carcinoma of the penis. BJU Int. 2012 Dec;110(11 Pt B):E661-6. doi: 10.1111/j.1464-410X.2012.11453.x. Epub 2012 Sep 10.

  PMID: 22958571 BACKGROUND

• Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marreaud S, Oliver RDT; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-1307. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.

  PMID: 18417462 BACKGROUND

• Power DG, Galvin DJ, Cuffe S, McVey GP, Mulholland PJ, Farrelly C, Delaney DW, O'Byrne KJ. Cisplatin and gemcitabine in the management of metastatic penile cancer. Urol Oncol. 2009 Mar-Apr;27(2):187-90. doi: 10.1016/j.urolonc.2007.10.015. Epub 2008 Feb 4.

  PMID: 18367122 BACKGROUND

• Di Lorenzo G, Federico P, Buonerba C, Longo N, Carteni G, Autorino R, Perdona S, Ferro M, Rescigno P, D'Aniello C, Matano E, Altieri V, Palmieri G, Imbimbo C, De Placido S, Mirone V. Paclitaxel in pretreated metastatic penile cancer: final results of a phase 2 study. Eur Urol. 2011 Dec;60(6):1280-4. doi: 10.1016/j.eururo.2011.08.028. Epub 2011 Aug 22.

  PMID: 21871710 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Moro C, Brunelli C, Miccinesi G, Fallai M, Morino P, Piazza M, Labianca R, Ripamonti C. Edmonton symptom assessment scale: Italian validation in two palliative care settings. Support Care Cancer. 2006 Jan;14(1):30-7. doi: 10.1007/s00520-005-0834-3. Epub 2005 Jun 4.

  PMID: 15937688 BACKGROUND

• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

  PMID: 2702835 BACKGROUND

• Young H, Baum R, Cremerius U, Herholz K, Hoekstra O, Lammertsma AA, Pruim J, Price P. Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Eur J Cancer. 1999 Dec;35(13):1773-82. doi: 10.1016/s0959-8049(99)00229-4.

  PMID: 10673991 BACKGROUND

MeSH Terms

Interventions

cabozantinib

Study Officials

• Daniele Raggi, MD

  Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  STUDY CHAIR

Central Study Contacts

Daniele Raggi, MD

CONTACT

+390223902402; daniele.raggi@istitutotumori.mi.it

Michela Rizzuti, Dr.ssa

CONTACT

+390223903067; michela.rizzuti@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: May 9, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)