A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer

Completed · Phase 2

Conditions studied: Ovarian Neoplasm

In brief

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

Key facts

Study ID

NCT00001426

Run by

National Cancer Institute (NCI)

People needed

66

Starts

1995-02-03

Expected to finish

2013-11-07

Last updated by the study team

2018-04-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).
• History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.
• Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.
• History of active GI bleeding within the last 30 days.
• Prior therapy other than surgery for this malignancy.
• Abnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.
• Previous history of invasive malignancy.
• Patients with ureteral obstruction must have this corrected prior to starting therapy.
• Patients with germ cell, mixed Muellerian and borderline histologies are specifically excluded.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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