This trial is active, not recruiting.

Conditions ovarian cancer, peritoneal cavity cancer
Treatments docetaxel, gemcitabine hydrochloride
Phase phase 2
Sponsor Barbara Ann Karmanos Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date February 2004
End date December 2014
Trial size 30 participants
Trial identifier NCT00227721, CDR0000445432, P30CA022453, WSU-C-2713


RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
docetaxel Taxotere®
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
gemcitabine hydrochloride Gemzar ®
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days

Primary Outcomes

Overall survival
time frame: From date of registration to date of death from any cause

Secondary Outcomes

Progression-free survival
time frame: Every two cycles

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial or peritoneal cavity cancer - Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen - Platinum-sensitive or -resistant disease - Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen - Measurable or evaluable disease - Evaluable disease is defined as CA 125 > 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken > 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL Hepatic - Bilirubin normal - Meets 1 of the following criteria: - AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN) - AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN - AST or ALT ≤ 5 times ULN AND AP normal Renal - Creatinine clearance > 30 mL/min - Creatinine < 2.5 mg/dL Cardiovascular - No congestive heart failure - No second or third degree heart block - No myocardial infarction within the past 3 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy > grade 1 - No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix - No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - Prior paclitaxel allowed - No more than 1 prior chemotherapy regimen - First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen - No prior gemcitabine or docetaxel Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - More than 28 days since prior and no other concurrent investigational drugs for this cancer - No other concurrent treatment or alternative therapy for this cancer

Additional Information

Official title Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
Principal investigator Robert T. Morris, MD
Description OBJECTIVES: Primary - Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel. Secondary - Determine the toxicity of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. - Determine the time to treatment failure and progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease). Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment). PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.