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

Alternate Title

Combination Chemotherapy and Surgery in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Not specified NCI SWOG-S0009 S0009, NCT00008138

Objectives

1. Determine the overall survival and progression-free survival in patients with stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant paclitaxel and carboplatin.
2. Determine the percentage of these patients whose disease is successfully cytoreduced to less than 1 cm in diameter following neoadjuvant chemotherapy.
3. Determine the toxicity of this regimen in these patients.
4. Determine the relationship between tumor p53 expression, proliferation rate as measured by proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay results at time of debulking surgery with progression-free survival and overall survival in these patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 55 patients will be accrued for this study within 3 years.

Outcomes

Overall survival

Outline

This is a multicenter study.

Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 5 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Amy Tiersten, MD, Protocol chair		Ph: 212-731-5349

Registry Information
Official Title		Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Trial Start Date		2001-03-15
Registered in ClinicalTrials.gov		NCT00008138
Date Submitted to PDQ		2000-11-20
Information Last Verified		2006-01-10
NCI Grant/Contract Number		U10-CA32102

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