RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining adjuvant intraperitoneal carboplatin with paclitaxel in treating patients who have undergone debulking surgery for stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Condition	Treatment or Intervention	Phase
Fallopian Tube Cancer ovarian epithelial cancer peritoneal cavity cancer	Drug: carboplatin  Drug: paclitaxel  Procedure: adjuvant therapy  Procedure: chemotherapy  Procedure: intraperitoneal therapy	Phase I

OBJECTIVES: Primary

• Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel in patients with stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.
• Determine the feasibility of this regimen in these patients.

Secondary

• Determine the toxicity profile of this regimen in these patients.
• Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for feasibility) will be accrued for this study within 15 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
• Stage III or IV disease
• The following histologic epithelial cell types are eligible:
• Serous adenocarcinoma
• Mucinous adenocarcinoma
• Clear cell adenocarcinoma
• Transitional cell carcinoma
• Adenocarcinoma not otherwise specified
• Endometrioid adenocarcinoma
• Undifferentiated carcinoma
• Mixed epithelial carcinoma
• Malignant Brenner's tumor
• Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)
• Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:
• Stage IB disease or less
• Less than 3 mm invasion without vascular or lymphatic invasion
• No poorly differentiated subtypes, including the following:
• Papillary serous
• Clear cell
• Other FIGO grade 3 lesions
• No epithelial tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No active bleeding

Hepatic

• AST ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN
• Bilirubin ≤ 1.5 times ULN
• No acute hepatitis

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for at least 6 months before study entry

Other

• No neuropathy (sensory and motor) > grade 1
• No active infection requiring antibiotics
• No circumstances that would preclude study participation
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• At least 3 years since prior adjuvant chemotherapy for localized breast cancer
• Patients must remain free of recurrent or metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
• Patient must remain free of recurrent or metastatic disease
• No prior radiotherapy to any portion of the abdominal cavity or pelvis

Surgery

• See Disease Characteristics

Other

• No prior therapy for this malignancy
• No prior cancer treatment that contraindicates study therapy
• No concurrent amifostine or other protective agents

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Missouri
      Siteman Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
      Ireland Cancer Center, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States; Recruiting

Study chairs or principal investigators

Mark A. Morgan, MD,  Study Chair,  University of Pennsylvania Cancer Center   

Study ID Numbers:  CDR0000355741; GOG-9917
Record last reviewed:  June 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079430
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05