Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Not specified NCI SWOG-S9912 S9912, NCT00003896

Objectives

1. 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.
2. Determine the feasibility of and toxic effects associated with this regimen in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• SWOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 62 patients will be accrued for this study within 4 years.

Outcomes

Progression-free survival

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Harriet Smith, MD, Protocol chair		Ph: 505-272-3392

Registry Information
Official Title		Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer
Trial Start Date		1999-09-15
Registered in ClinicalTrials.gov		NCT00003896
Date Submitted to PDQ		1999-05-07
Information Last Verified		2005-09-14
NCI Grant/Contract Number		CA32102

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