Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
18 Years
N/A
Female
Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
From date of registration to date of death from any cause
Safety Issue:
No
Principal Investigator
Robert T. Morris, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000445432
NCT ID:
NCT00227721
Start Date:
February 2004
Completion Date:
Related Keywords:
- Ovarian Cancer
- Peritoneal Cavity Cancer
- recurrent ovarian epithelial cancer
- peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Sinai-Grace Hospital | Detroit, Michigan 48235 |
