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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Eli Lilly and Company
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183794
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: December 2012
  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 University of Southern California:

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:

  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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Southern California
Aventis Pharmaceuticals
Eli Lilly and Company
Investigators
Principal Investigator: Agustin Garcia, MD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
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: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Primary Peritoneal

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
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 September 18, 2014