Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Ovarian Neoplasm

Eligibility:

FEMALE

Phase:

PHASE2

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 p...

Detailed Description

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 p...

Eligibility Criteria

  • 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.

EXCLUSION CRITERIA:

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.

Key Trial Info

Start Date :

February 3 1995

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 7 2013

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT00001426

Start Date

February 3 1995

End Date

November 7 2013

Last Update

April 5 2018

Active Locations (1)

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1

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

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