Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005051

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-08-31

Completion date

Unknown

Last updated

2012-11-09

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

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.

Detailed description

OBJECTIVES: * Determine the toxicity and tolerance of sequential therapy with prolonged * Determine the response rate and time to progression in this patient * Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route. OUTLINE: * Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses. * Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.

Interventions

DRUGcarboplatin

DRUGcisplatin

DRUGpaclitaxel

DRUGtopotecan hydrochloride

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery * Stage IC, II, III, or IV PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * SGOT no greater than 3 times upper limit of normal * Bilirubin no greater than 2.0 mg/dL * No clinically significant hepatic disorder Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * No clinically significant renal disorder Cardiovascular: * No clinically significant cardiovascular condition Other: * Normal GI function allowing reliable administration of oral medication * No active infection requiring systemic medical therapy within past week * No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder) * No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No dementia or altered mental status that would preclude consent * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for ovarian epithelial carcinoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for ovarian epithelial carcinoma Surgery: * See Disease Characteristics

Countries

United States

Outcome results

None listed

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