Sponsor study identifier
observational
0
1 country
1
Study Start
May 2006
Actual (reported)Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Actual (reported)June 7, 2007
Actual (reported)June 11, 2007
Actual (reported)May 2009
Actual (reported)May 2009
Actual (reported)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
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
Females over 18 years of age
Carilion GYN Oncology Associates
Roanoke, Virginia, 24014, United States
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.
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.
Dennis R Scribner, JR, MD
Carilion Clinic
0 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2007
First Posted
June 11, 2007
Study Start
May 2006
Actual (reported)Primary Completion
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Contact the study team to confirm eligibility.
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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.
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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.
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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.
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.
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.
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.
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.
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.
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.
Vasey PA et. al. Proc Am Soc Clin Onc 2001;20:Abst.1370.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hycamtin (topotecan) package insert. GlaxoSmithKline. Research Triangle Park, NC. Revised 11/2002.
Taxotere (docetaxel) package insert. Aventis Pharmaceuticals, Inc. Bridgewater, NJ. Revised: April/2003.
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
September 16, 2019
Record last verified: 2019-09
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