Status:
COMPLETED
A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
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 canc...
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 canc...
Eligibility Criteria
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.
Key Trial Info
Start Date :
September 1 1991
Trial Type :
INTERVENTIONAL
End Date :
May 1 2000
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00001272
Start Date
September 1 1991
End Date
May 1 2000
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892