Phase 2
N=58
S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
Fallopian Tube Cancer · Ovarian Cancer · Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00008138 ↗Enrolled (actual)
58
Serious AEs
1.2%
Results posted
Aug 2012
Primary outcome: Primary: Overall Survival — 32 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug); debulking surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
32 | — |
| PRIMARY Progression-Free Survival |
21 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
- Adenocarcinoma
- Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion
- Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)
- No borderline or low-malignant potential tumors
- Optimal cytoreduction clinically deemed unlikely
- CA 125 at least 70 units/mL
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT no greater than 2 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No congestive heart failure or cardiac arrhythmia
- No myocardial infarction or angina within past 6 months
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding
- No grade 2 or greater sensory neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
- No active or uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for this cancer
Chemotherapy:
- No prior chemotherapy for this cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior pelvic radiation for this cancer
Surgery:
- See Disease Characteristics
- Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)
- Prior salpingo-oophorectomy and/or partial omentectomy allowed
Other:
- No other concurrent anti-cancer therapy
Data sourced from ClinicalTrials.gov (NCT00008138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.