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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
This study has been completed.
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001272
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: taxol
Phase I

Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 60
Study Start Date: September 1991
Estimated Study Completion Date: May 2000
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001272

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 910232, 91-C-0232
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001272     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adult
Cytotoxic Chemotherapy
Hematopoietic Growth Factor

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009