A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis

NCT03114254 | Completed Phase 2 DMC

• 3 other identifiers: ON/2012/42332014-002336-14CabazL05881
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis. Safety and tolerability will be monitored and survival will be assessed. It is hypothesised that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.

Conditions

Penile Neoplasm

Keywords

Recurrent; Locally advanced; Metastatic

Outcome Measures

Primary Outcomes (2)

• Complete response

  Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

  18 weeks

• Partial response

  Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

  18 weeks

Secondary Outcomes (4)

• Progression free survival

  Until patient progresses, which is approximately 6 weeks after randomisation

• Overall survival

  Until patient dies, which is approximately 3 months after randomisation

• Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).

  After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint

• Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).

  From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint.

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Six cycles of chemotherapy comprising: Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

Six cycles of chemotherapy comprising: Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days.

Also known as: Jetvana

Cabazitaxel

Eligibility Criteria

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

You may qualify if:

• Histologically-proven squamous cell carcinoma of the penis
• Performance status ECOG 0-2
• Written informed consent
• Measurable disease as per RECIST 1.1
• Fit to receive cabazitaxel as second line chemotherapy
• Previously received TPF or cisplatin-5FU as first line systemic chemotherapy for penile cancer
• Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrollment:
• Neutrophils ≥1.5 x 109/L
• Haemoglobin ≥10 g/dL
• Platelets ≥100 x 109/L
• Total bilirubin \<1.5 upper limit of normal (ULN)
• Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤1.5 x ULN
• Serum creatinine ≤1.5 x ULN. (If creatinine is 1.0-1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with a creatinine clearance \<60 ml/min should be excluded.)

You may not qualify if:

• Pure veruccous carcinoma of the penis
• Squamous carcinoma of the urethra
• T1 N1 M0 disease
• T2 N1 M0 disease
• Unfit for this regimen (as assessed by the multidisciplinary team)
• Contraindication to chemotherapy
• ECOG Performance Status \> 2
• Active Grade ≥2 peripheral neuropathy
• Active secondary cancers
• Other concurrent serious illness or medical conditions
• Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
• Uncontrolled diabetes mellitus.
• History of severe hypersensitivity reaction (≥grade 3) to docetaxel
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
• Active infection requiring systemic antibiotic or anti-fungal medication

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• Sanofi: collaborator

Study Sites (2)

Bristol Haematology and Oncology Centre, Horfield Road

Bristol, BS2 8ED, United Kingdom

Location

Universitty College Hospitals NHS Trust

London, United Kingdom

Location

Related Publications (20)

• Seixas AL, Ornellas AA, Marota A, Wisnescky A, Campos F, de Moraes JR. Verrucous carcinoma of the penis: retrospective analysis of 32 cases. J Urol. 1994 Nov;152(5 Pt 1):1476-8; discussion 1478-9. doi: 10.1016/s0022-5347(17)32450-3.

  PMID: 7933188 BACKGROUND

• Soria JC, Fizazi K, Piron D, Kramar A, Gerbaulet A, Haie-Meder C, Perrin JL, Court B, Wibault P, Theodore C. Squamous cell carcinoma of the penis: multivariate analysis of prognostic factors and natural history in monocentric study with a conservative policy. Ann Oncol. 1997 Nov;8(11):1089-98. doi: 10.1023/a:1008248319036.

  PMID: 9426328 BACKGROUND

• Cubilla AL, Ayala MT, Barreto JE, Bellasai JG, Noel JC. Surface adenosquamous carcinoma of the penis. A report of three cases. Am J Surg Pathol. 1996 Feb;20(2):156-60. doi: 10.1097/00000478-199602000-00003.

  PMID: 8554104 BACKGROUND

• Somogyi L, Kalman E. Metaplastic carcinoma of the penis. J Urol. 1998 Dec;160(6 Pt 1):2152-3. doi: 10.1097/00005392-199812010-00059. No abstract available.

  PMID: 9817349 BACKGROUND

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• Wood EW, Gardner WA Jr, Brown FM. Spindle cell squamous carcinoma of the penis. J Urol. 1972 Jun;107(6):990-1. doi: 10.1016/s0022-5347(17)61190-x. No abstract available.

  PMID: 5033986 BACKGROUND

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  PMID: 3573181 BACKGROUND

• Ravi R. Correlation between the extent of nodal involvement and survival following groin dissection for carcinoma of the penis. Br J Urol. 1993 Nov;72(5 Pt 2):817-9. doi: 10.1111/j.1464-410x.1993.tb16273.x.

  PMID: 8281416 BACKGROUND

• Slaton JW, Morgenstern N, Levy DA, Santos MW Jr, Tamboli P, Ro JY, Ayala AG, Pettaway CA. Tumor stage, vascular invasion and the percentage of poorly differentiated cancer: independent prognosticators for inguinal lymph node metastasis in penile squamous cancer. J Urol. 2001 Apr;165(4):1138-42.

  PMID: 11257655 BACKGROUND

• Solsona E, Iborra I, Rubio J, Casanova JL, Ricos JV, Calabuig C. Prospective validation of the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative inguinal lymph nodes. J Urol. 2001 May;165(5):1506-9.

  PMID: 11342906 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.

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• 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

• Ahmed T, Sklaroff R, Yagoda A. Sequential trials of methotrexate, cisplatin and bleomycin for penile cancer. J Urol. 1984 Sep;132(3):465-8. doi: 10.1016/s0022-5347(17)49693-5.

  PMID: 6206239 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

• Sklaroff RB, Yagoda A. Cis-diamminedichloride platinum II (DDP) in the treatment of penile carcinoma. Cancer. 1979 Nov;44(5):1563-5. doi: 10.1002/1097-0142(197911)44:53.0.co;2-s.

  PMID: 498030 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

• Oudard S. TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011 Apr;7(4):497-506. doi: 10.2217/fon.11.23.

  PMID: 21463139 BACKGROUND

MeSH Terms

Conditions

Penile Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Amit Bahl

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

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: October 30, 2014
• First Posted: April 14, 2017
• Study Start: December 5, 2014
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

GB (2)