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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001426

Collaborator

(none)

Enrollment

Location

225.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasm	Drug: Cyclophosphamide Drug: Paclitaxel Drug: Cisplatin Drug: G-CSF	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 3, 1995

Actual Primary Completion Date :

Oct 15, 2007

Actual Study Completion Date :

Nov 7, 2013

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.

Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.

Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.

Performance status of less than or equal to ECOG 2.

Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.

All patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.