Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

NCT ID: NCT00183794

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2010-05-31

Brief Summary

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.

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:

1. To determine the toxicity of this combination regimen in patients with platinum-resistant ovarian cancer

2. 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.

Conditions

Ovarian Carcinoma; Peritoneal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Docetaxel and Gemcitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agustin Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

5GYN-02-2

Identifier Type: -

Identifier Source: org_study_id