Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: carboplatin; paclitaxel; cytoreductive surgery
Intervention description: Carboplatin dose (milligrams (mg)) - Target Area Under the Curve (AUC) 6 x (Glomerular Filtration Rate+25) - Calvert Formula, given intravenously (IV) for 30 minutes.; Paclitaxel dose = 175 milligrams per meter squared (mg/m2) over 3 hours.; Surgery - tumor specimen collected for extreme drug resistant assay (EDR) and A1 assays for analysis
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian clear cell cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian mixed epithelial carcinoma; ovarian mucinous cystadenocarcinoma; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; peritoneal cavity cancer; fallopian tube cancer; Brenner tumor

Summary:

      RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or stopping them from
      dividing. Giving chemotherapy drugs before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
      before surgery works in treating patients with advanced ovarian epithelial cancer, fallopian
      tube cancer, or primary peritoneal cavity cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histological diagnosis of epithelial ovarian, primary peritoneal, or
             fallopian tube carcinoma for which no previous treatment has been given.

        Patients with the following histological epithelial cell types are eligible:

          -  Serous adenocarcinoma

          -  Mucinous adenocarcinoma

          -  Clear cell adenocarcinoma

          -  Transitional cell

          -  Adenocarcinoma not otherwise specified

          -  Endometrioid adenocarcinoma

          -  Undifferentiated carcinoma

          -  Mixed epithelial carcinoma

          -  Malignant Brenner's tumor

               -  Measurable or non-measurable disease as defined by Solid Tumor Response Criteria
                  (RECIST) within 4 weeks of study entry

               -  High-risk surgical candidate

               -  Gynecologic Oncology Group (GOG) performance status 0-3

               -  Absolute neutrophil count ≥ 1,500/mm^3

               -  Platelet count ≥ 100,000/mm^3

               -  Creatinine ≤ 1.5 mg/dL

               -  Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)

               -  Bilirubin ≤ 1.5 times ULN

               -  Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times ULN

               -  Life expectancy ≥ 12 weeks

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Positive pregnancy test -(Fertile patients must use effective nonhormonal
             contraception during and for 3 months after completion of study treatment.)

          -  History of another neoplasm except for non-metastatic, non-melanoma skin cancers,
             carcinoma in situ of the cervix, or cancer cured by surgery > 5 years prior to
             registration.

          -  Septicemia, severe infection, acute hepatitis, or severe gastrointestinal bleeding,
             defined as requiring blood transfusion or hospitalization at registration

          -  Unstable angina will not be eligible. Patients with evidence of abnormal cardiac
             conduction (e.g. bundle branch block, heart block) are eligible if their disease has
             been stable for the past six months.

          -  History of severe hypersensitivity or allergic reaction to study drugs, drugs
             formulated in Cremophor EL^®, other platinol compounds, or mannitol