Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, peritoneal cavity cancer
Brief summary
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.
Detailed 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.
Interventions
DRUGDocetaxel
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
DRUGGemcitabine hydrochloride
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Sponsors
National Cancer Institute (NCI)
Robert Morris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer. | Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Every two cycles until disease progression or death, assessed up to 5 years | Progression-free survival estimated using Kaplan-Meier's product-limit method. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel & Gemcitabine Hydrochloride 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: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | On study, but never treated. | 1 |
Baseline characteristics
| Characteristic | Docetaxel & Gemcitabine Hydrochloride |
|---|---|
| Age, Continuous | 57.5 years |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 30 |
| other Total, other adverse events | 24 / 29 |
| serious Total, serious adverse events | 14 / 29 |
Outcome results
Primary
Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.
Time frame: Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel & Gemcitabine Hydrochloride | Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer. | 62 percentage of participants with CR or PR |
Secondary
Progression-free Survival
Progression-free survival estimated using Kaplan-Meier's product-limit method.
Time frame: Every two cycles until disease progression or death, assessed up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel & Gemcitabine Hydrochloride | Progression-free Survival | 7.2 months |