Combination Chemotherapy in Treating Patients With Previously Untreated Stage III or Stage IV Ovarian or Primary Peritoneal Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003378
First received: November 1, 1999
Last updated: July 8, 2013
Last verified: December 2011
  Purpose

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 may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage IV ovarian or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 45
Study Start Date: August 1998
Primary Completion Date: February 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response rate (in patients with measurable disease) and progression-free interval in these patients receiving this treatment.

OUTLINE: This is a feasibility study. On day 1, patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every 21 days for a maximum of 8 courses. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within approximately 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated: Stage III or stage IV ovarian epithelial cancer Stage III or stage IV primary peritoneal cancer

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Effective contraception required of fertile patients No significant infections No other severe medical problems that would subject patient to undue risk from this protocol No other active malignancy within past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this or any other malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for this or any other malignancy Surgery: No prior surgery other than cytoreductive surgery and recovered

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003378

  Show 64 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Katherine Y. Look, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003378     History of Changes
Other Study ID Numbers: CDR0000066372, GOG-9801
Study First Received: November 1, 1999
Last Updated: July 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Gemcitabine
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014