Patient case: 64-year-old female with ovarian cancer; genetic feature: BRCA1

Clinical trial: S9912 Combination Chemo in Stage III Ovarian Cancer,

Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  -  Determine the feasibility of and toxic effects associated with this regimen in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 6 months for 2 years and then annually thereafter.
  PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
  -  Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
  -  No tumors of borderline or low malignant potential only
  -  Mixed Mullerian tumors allowed
  -  Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
  -  Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  SWOG 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Granulocyte count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  Hepatic:
  -  Bilirubin ≤ 2 times upper limit of normal (ULN)
  -  SGOT or SGPT ≤ 2 times ULN
  Renal:
  -  Creatinine clearance ≥ 50 mL/min
  Cardiovascular:
  -  No congestive heart failure
  -  No cardiac arrhythmia
  -  No myocardial infarction or unstable angina within the past 6 months
  -  Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No active or uncontrolled infection
  -  No concurrent fever
  -  No grade 2 or greater sensory neuropathy
  -  No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
  -  No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
  -  No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior immunotherapy for ovarian cancer
  Chemotherapy:
  -  No prior chemotherapy for ovarian cancer
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior pelvic radiotherapy for ovarian cancer
  Surgery:
  -  See Disease Characteristics
  -  Recovered from all reversible surgery-related toxic effects
  Other:
  -  No other concurrent antitumor treatment
  -  No concurrent antibiotics for infection of undetermined etiology

Relevance to patient case: not relevant