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

A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003378

Enrollment

Registered

2004-08-26

Start date

1998-08-31

Completion date

Unknown

Last updated

2013-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer

Brief summary

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.

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.

Interventions

DRUGcarboplatin

DRUGgemcitabine hydrochloride

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026