Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

NCT00484666 | Withdrawn DMC

• 1 other identifier: Topo Txt
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer. Secondary objectives: To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer To estimate the progression free survival (PFS) and overall survival (OS) for women with recurrent platinum resistant ovarian or primary peritoneal cancer treated with this weekly docetaxel and weekly topotecan.

Conditions

Ovarian Cancer

Keywords

recurrent; platinum; resistant; ovarian; primary; peritoneal; cancer

Outcome Measures

Primary Outcomes (1)

• To estimate the overall clinical response rate (CR, PR, SD) of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer.

  12 Months

Secondary Outcomes (1)

• To access the safety and tolerability of this novel combination chemotherapy regimen of weekly docetaxel and weekly topotecan in women with recurrent platinum resistant ovarian or primary peritoneal cancer

  12 Months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological sex based
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females over 18 years of age

You may qualify if:

• All patients will have had histologically documented ovarian epithelial, fallopian tube or peritoneal cancer.
• Patients must have received one prior platinum- and paclitaxel based regimen
• Patients must be platinum-resistant defined as recurrence or progression of disease \<6 months since previous treatment with a platinum based treatment regimen.
• Patients must not have received radiotherapy.
• Patients with the following histologic epithelial cell types are eligible:
• Serous Adenocarcinoma
• Endometrioid Adenocarcinoma
• Mucinous Adenocarcinoma
• Undifferentiated carcinoma
• Clear cell Adenocarcinoma
• Mixed epithelial carcinoma
• Transitional cell
• Malignant Brenner's tumor
• Adenocarcinoma NOS
• Patients may have measurable or evaluable disease whereas evaluable disease is defined as new onset pleural effusion, ascites or a rise in CA-125 level \>2x institutions upper limit of normal x 2 now sooner than one week apart.

You may not qualify if:

• Patients with borderline ovarian cancer.
• Patients with GOG performance status 3 or 4.
• Patients who have received prior topotecan and/or docetaxel.
• Patients who have a history of psychiatric illness or other concurrent severe and/or uncontrolled co-morbid medical condition that would preclude study completion (i.e., uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within 6 months, congestive heart failure).
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer or any evidence of the other cancer(s) present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
• Patients with a history of severe acute hypersensitivity reaction to medications formulated with polysorbate 80.
• Patients with baseline peripheral neuropathy ≥ Grade 2.
• No use of investigational drugs or alternative medicine anticancer therapy within the last 4 weeks of 1st dose of study drug.
• Pregnant or lactating women with reproductive potential. (All patients enrolled in this study will be postmenopausal or have undergone surgery that includes hysterectomy and oophorectomy that would render them unable to conceive children.)

Sponsors & Collaborators

• Carilion Clinic: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Carilion GYN Oncology Associates

Roanoke, Virginia, 24014, United States

Location

Related Publications (33)

• Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92. doi: 10.1200/JCO.2000.18.17.3084.

  PMID: 10963636 BACKGROUND

• Papadimitriou CA, Moulopoulos LA, Vlahos G, Voulgaris Z, Kiosses E, Georgoulias N, Gika D, Diakomanolis E, Michalas S, Dimopoulos MA. Paclitaxel, cisplatin, and epirubicin first-line chemotherapy in stage III and IV ovarian carcinoma: long-term results of a phase II study. Cancer. 2000 Oct 1;89(7):1547-54. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-p.

  PMID: 11013370 BACKGROUND

• Ozols RF, Bundy BN, Fowler J, Clarke-Pearson D, Mannel R, Hartenbach EM, Baergen R. Randomized phase III study of cisplatin/paclitaxel versus carboplatin/paclitaxel in optimal stage III epithelial ovarian cancer: A GOG trial. Proc Am Soc Clinic Onc 1999;18:356a.

  BACKGROUND

• Berek JS, Bertelsen K, du Bois A, Brady MF, Carmichael J, Eisenhauer EA, Gore M, Grenman S, Hamilton TC, Hansen SW, Harper PG, Horvath G, Kaye SB, Luck HJ, Lund B, McGuire WP, Neijt JP, Ozols RF, Parmar MK, Piccart-Gebhart MJ, van Rijswijk R, Rosenberg P, Rustin GJ, Sessa C, Willemse PH, et al. Advanced epithelial ovarian cancer: 1998 consensus statements. Ann Oncol. 1999;10 Suppl 1:87-92. doi: 10.1023/a:1008323922057.

  PMID: 10219460 BACKGROUND

• Markman M, Rothman R, Hakes T, Reichman B, Hoskins W, Rubin S, Jones W, Almadrones L, Lewis JL Jr. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol. 1991 Mar;9(3):389-93. doi: 10.1200/JCO.1991.9.3.389.

  PMID: 1999708 BACKGROUND

• Thigpen JT, Blessing JA, Ball H, Hummel SJ, Barrett RJ. Phase II trial of paclitaxel in patients with progressive ovarian carcinoma after platinum-based chemotherapy: a Gynecologic Oncology Group study. J Clin Oncol. 1994 Sep;12(9):1748-53. doi: 10.1200/JCO.1994.12.9.1748.

  PMID: 7916038 BACKGROUND

• Kavanagh J, Tresukosol D, Edwards C, Freedman R, Gonzalez de Leon C, Fishman A, Mante R, Hord M, Kudelka A. Carboplatin reinduction after taxane in patients with platinum-refractory epithelial ovarian cancer. J Clin Oncol. 1995 Jul;13(7):1584-8. doi: 10.1200/JCO.1995.13.7.1584.

  PMID: 7602347 BACKGROUND

• Gore M, ten Bokkel Huinink W, Carmichael J, Gordon A, Davidson N, Coleman R, Spaczynski M, Heron JF, Bolis G, Malmstrom H, Malfetano J, Scarabelli C, Vennin P, Ross G, Fields SZ. Clinical evidence for topotecan-paclitaxel non--cross-resistance in ovarian cancer. J Clin Oncol. 2001 Apr 1;19(7):1893-900. doi: 10.1200/JCO.2001.19.7.1893.

  PMID: 11283120 BACKGROUND

• Homesley HD, Hall DJ, Martin DA, Lewandowski GS, Vaccarello L, Nahhas WA, Suggs CL, Penley RG. A dose-escalating study of weekly bolus topotecan in previously treated ovarian cancer patients. Gynecol Oncol. 2001 Nov;83(2):394-9. doi: 10.1006/gyno.2001.6435.

  PMID: 11606103 BACKGROUND

• Morris RT, Munkarah A, Field J, Baker VV, Drake R, Malone J. Phase II trial of weekly topotecan in patients with potentially platinum sensitive relapsed ovarian and peritoneal cancer. Proc ASCO, 2002; 2512A.

  BACKGROUND

• Abu-Rustum NR, Aghajanian C, Barakat RR, Fennelly D, Shapiro F, Spriggs D. Salvage weekly paclitaxel in recurrent ovarian cancer. Semin Oncol. 1997 Oct;24(5 Suppl 15):S15-62-S15-67.

  PMID: 9346225 BACKGROUND

• Markman M, Hall J, Spitz D, Weiner S, Carson L, Van Le L, Baker M. Phase II trial of weekly single-agent paclitaxel in platinum/paclitaxel-refractory ovarian cancer. J Clin Oncol. 2002 May 1;20(9):2365-9. doi: 10.1200/JCO.2002.09.130.

  PMID: 11981009 BACKGROUND

• Aapro MS, Pujade-Lauriane E, et al. EORTC Clinical Screening Group: Phase II study of Taxotere in ovarian cancer. Annals of Oncology 5(5):202, abstract 508, 1994.

  BACKGROUND

• Francis P, Schneider J, Hann L, Balmaceda C, Barakat R, Phillips M, Hakes T. Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J Clin Oncol. 1994 Nov;12(11):2301-8. doi: 10.1200/JCO.1994.12.11.2301.

  PMID: 7964944 BACKGROUND

• Kavanagh JJ, Kudelka AP, de Leon CG, Tresukosol D, Hord M, Finnegan MB, Kim EE, Varma D, Forman A, Cohen P, Edwards CL, Freedman RS, Verschraegen CF. Phase II study of docetaxel in patients with epithelial ovarian carcinoma refractory to platinum. Clin Cancer Res. 1996 May;2(5):837-42.

  PMID: 9816238 BACKGROUND

• Piccart MJ, Gore M, Ten Bokkel Huinink W, Van Oosterom A, Verweij J, Wanders J, Franklin H, Bayssas M, Kaye S. Docetaxel: an active new drug for treatment of advanced epithelial ovarian cancer. J Natl Cancer Inst. 1995 May 3;87(9):676-81. doi: 10.1093/jnci/87.9.676.

  PMID: 7752272 BACKGROUND

• Markman M, Kennedy A, Webster K, Peterson G, Kulp B, Belinson J. Combination chemotherapy with carboplatin and docetaxel in the treatment of cancers of the ovary and fallopian tube and primary carcinoma of the peritoneum. J Clin Oncol. 2001 Apr 1;19(7):1901-5. doi: 10.1200/JCO.2001.19.7.1901.

  PMID: 11283121 BACKGROUND

• Vasey PA, Atkinson R, Coleman R, Crawford M, Cruickshank M, Eggleton P, Fleming D, Graham J, Parkin D, Paul J, Reed NS, Kaye SB. Docetaxel-carboplatin as first line chemotherapy for epithelial ovarian cancer. Br J Cancer. 2001 Jan;84(2):170-8. doi: 10.1054/bjoc.2000.1572.

  PMID: 11161372 BACKGROUND

• Vasey PA et. al. Proc Am Soc Clin Onc 2001;20:Abst.1370.

  BACKGROUND

• Kuzur ME, Jones S, Willcutt N, et al. The Sarah Cannon Cancer Center/Tennessee Oncology, Nashville, TN; Glaxo Smith Kline, Philadelphia, PA: A phase I trial of weekly topotecan and docetaxel. Proc Am Soc Clin Onc 2003;22:Abst.

  BACKGROUND

• Hainsworth JD, Burris HA 3rd, Erland JB, Thomas M, Greco FA. Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol. 1998 Jun;16(6):2164-8. doi: 10.1200/JCO.1998.16.6.2164.

  PMID: 9626217 BACKGROUND

• Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, Matulonis UA, Garber JE, Clarke KD, Shulman LN, Winer EP. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol. 2000 Mar;18(6):1212-9. doi: 10.1200/JCO.2000.18.6.1212.

  PMID: 10715290 BACKGROUND

• Stemmler J, Mair W, Stauch M, et al. Weekly docetaxel with or without corticosteroid premedication as first or second-line treatment in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol. 2002;21:58a. Abstract 231.

  BACKGROUND

• Hainsworth JD, Burris HA 3rd, Yardley DA, Bradof JE, Grimaldi M, Kalman LA, Sullivan T, Baker M, Erland JB, Greco FA. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial. J Clin Oncol. 2001 Aug 1;19(15):3500-5. doi: 10.1200/JCO.2001.19.15.3500.

  PMID: 11481356 BACKGROUND

• Climent MA, Tabernero J, Albanell J, et al. Preliminary results of a phase II randomized trial of docetaxel (taxotere) as a single agent chemotherapy (CT) administered weekly or 3-weekly in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol.2002;21:52a. Abstract 205.

  BACKGROUND

• Hainsworth JD, Burris HA 3rd, Litchy S, Morrissey LH, Barton JH, Bradof JE, Greco FA. Weekly docetaxel in the treatment of elderly patients with advanced nonsmall cell lung carcinoma. A Minnie Pearl Cancer Research Network Phase II Trial. Cancer. 2000 Jul 15;89(2):328-33. doi: 10.1002/1097-0142(20000715)89:23.0.co;2-f.

  PMID: 10918162 BACKGROUND

• Lilenbaum RC, Schwartz MA, Seigel L, Belette F, Blaustein A, Wittlin FN, Davila E. Phase II trial of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma. Cancer. 2001 Oct 15;92(8):2158-63. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-2.

  PMID: 11596033 BACKGROUND

• McKay C III, Hainsworth J, Burris H III, et al. Weekly docetaxel/gemcitabine in the treatment of elderly patients (pts) with advanced non-small cell lung cancer (NSCLC): a Minnie Pearl Cancer Research Network phase II trial. Proc Am Soc Clin Oncol. 2001;20:260b. Abstract 2793.

  BACKGROUND

• Gervais R, Ducoloné AMD, Breton J-L, et al. Multicenter, randomised, phase II trial of docetaxel (Taxotere) 75 mg/m2 q3w versus 40 mg/m2 weekly in patients with pretreated non small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2002;21:310a. Abstract 1238.

  BACKGROUND

• Schütte W, Nagel S, Lautenschläger C, et al. Randomized phase III study of weekly versus three-weekly docetaxel as second-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2002;21:308a. Abstract 1228.

  BACKGROUND

• Kuzur, ME, Jones S, Willcutt N, et.al. A phase I trial of weekly topotecan and docetaxel. Proc Am Soc Clin Oncol. 2003;22: Abstract 2840.

  BACKGROUND

• Hycamtin (topotecan) package insert. GlaxoSmithKline. Research Triangle Park, NC. Revised 11/2002.

  BACKGROUND

• Taxotere (docetaxel) package insert. Aventis Pharmaceuticals, Inc. Bridgewater, NJ. Revised: April/2003.

  BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis R Scribner, JR, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 11, 2007
• Study Start: May 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

US (1)