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

Phase 1
Not Enrolling
Ovarian Neoplasms

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Trial Information

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

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

Inclusion 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

September 1991

Completion Date:

May 2000

Related Keywords:

  • Ovarian Neoplasms
  • Adult
  • Cytotoxic Chemotherapy
  • Hematopoietic Growth Factor
  • Neoplasms
  • Ovarian Neoplasms



National Cancer Institute (NCI) Bethesda, Maryland  20892