Search / Trial NCT00002568

Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer

Launched by GYNECOLOGIC ONCOLOGY GROUP · May 4, 2004

Trial Information

Current as of November 04, 2024

Completed

Keywords

Stage Iii Ovarian Epithelial Cancer Ovarian Undifferentiated Adenocarcinoma Ovarian Mixed Epithelial Carcinoma Ovarian Serous Cystadenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Clear Cell Cystadenocarcinoma Brenner Tumor

ClinConnect Summary

OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.

OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A:...

Gender

FEMALE

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136
  • PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients
  • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging surgery

About Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG) is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of gynecologic cancers. Comprising a network of experts in the field, GOG conducts rigorous, multi-institutional research to evaluate innovative therapeutic strategies and improve patient outcomes. Through its commitment to high-quality clinical trials, the organization aims to enhance the standard of care for women diagnosed with gynecologic malignancies, fostering collaborations with academic institutions and industry partners to translate scientific discoveries into effective treatments. GOG's mission emphasizes patient safety, ethical research practices, and the dissemination of findings to benefit the broader medical community.

Locations

New York, New York, United States

Houston, Texas, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Orange, California, United States

Stanford, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Camden, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Abington, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Phoenix, Arizona, United States

Palo Alto, California, United States

Memphis, Tennessee, United States

Morristown, New Jersey, United States

Nashville, Tennessee, United States

Portland, Oregon, United States

Washington, District Of Columbia, United States

Manhasset, New York, United States

Cleveland, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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