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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008138 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Study Start Date: | March 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study ID Numbers: | CDR0000068380, SWOG-S0009 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008138 |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma |
ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer peritoneal cavity cancer |
Cystadenocarcinoma, Serous Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Fallopian Tube Diseases Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Peritoneal Neoplasms Fallopian tube cancer Endocrinopathy Adenocarcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Adnexal Diseases |