Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
This study has been completed.
Sponsor:
USC/Norris Comprehensive Cancer Center
Collaborators:
Aventis Pharmaceuticals
Eli Lilly and Company
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00183794
First received: September 9, 2005
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
This study is for patients with advanced ovarian cancer that has reappeared after treatment with conventional therapy. The purpose of this study is to determine if the combination of docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in patients with ovarian cancer.
Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer. Both drugs have been shown to decrease the size of ovarian cancer tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Carcinoma Peritoneal Neoplasms |
Drug: Docetaxel and Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma |
Resource links provided by NLM:
Further study details as provided by USC/Norris Comprehensive Cancer Center:
Primary Outcome Measures:
- Tumor Response Type: CR, PR, SD or PD [ Time Frame: 6 months after enrollment of last participant ] [ Designated as safety issue: No ]Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.
Secondary Outcome Measures:
- Median Time to Progression (Months) [ Time Frame: 6 months after enrollment of last patient ] [ Designated as safety issue: No ]Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)
| Enrollment: | 20 |
| Study Start Date: | November 2002 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
|
Drug: Docetaxel and Gemcitabine
Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.
|
Detailed Description:
Primary Objective:
1. To determine the response rate, time to progression and survival (secondary) of the combination of docetaxel and gemcitabine administered on a weekly basis to patients with platinum-resistant ovarian cancer
Secondary Objective:
- To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer
- To evaluate the toxicity and safety profile of a short course (one dose) of premedication with steroids to patients receiving weekly gemcitabine and docetaxel
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity, or patient's withdrawal.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven diagnosis of epithelial ovarian ca
- Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse < 6 months after the most recent platinum-based chemotx regimen.)
- Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated CA-125 [greater than or equal to 100] are eligible. If an elevated CA-125 is the only manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart. Patients with positive cytology only are not eligible.)
- Greater than or equal to 18 years of age
- GOG performance status less than or equal to 2
- AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000; hemoglobin (Hgb) greater than or equal to 8.0.
- Creatinine less than or equal to 2.0
- Total bilirubin less than or equal to upper limit of normal (uln)
- SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases are less than or equal to uln. (If both SGOT/SGPT >1.5 x uln and alkaline phosphatase > 2.5 x uln, patient is not eligible.)
- Fully recovered from acute toxicities secondary to prior treatment (tx)
- Signed informed consent
Exclusion Criteria:
- Prior treatment with gemcitabine or docetaxel
- Underlying medical, psychiatric, or social conditions that would preclude patient from receiving treatment
- Peripheral neuropathy greater than or equal to Grade 2
- No prior tx with cisplatin or carboplatin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183794
Locations
| United States, California | |
| Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Aventis Pharmaceuticals
Eli Lilly and Company
Investigators
| Principal Investigator: | Agustin Garcia, MD | University of Southern California |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00183794 History of Changes |
| Other Study ID Numbers: | 5GYN-02-2 |
| Study First Received: | September 9, 2005 |
| Results First Received: | October 6, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
Primary Peritoneal |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Neoplasms, Glandular and Epithelial Peritoneal Neoplasms Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms Abdominal Neoplasms Digestive System Neoplasms Carcinoma Adnexal Diseases Genital Diseases, Female |
Endocrine System Diseases Gonadal Disorders Digestive System Diseases Peritoneal Diseases Gemcitabine Docetaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013