A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients

March 3, 2008 updated by: National Cancer Institute (NCI)
This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI.

Germ cell and borderline histologies are specifically excluded.

Patients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy.

Prior chemotherapy or radiation therapy will make a patient ineligible.

Performance status: less than or equal to ECOG 2.

Patients must have the following end organ function:

No brain involvement.

No history of myocardial infarction, cardiac arrhythmias requiring

therapy, right bundle branch block with left anterior hemiblock, and left bundle branch block.

Renal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy.

Hepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal.

Neurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay).

No recent history of active GI bleeding.

Hematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000.

Patients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated.

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

Patients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1991

Study Completion

May 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (ESTIMATE)

December 10, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

June 1, 1999

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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