Completed

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

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What is being tested

taxol

Drug
Who is being recruted

Ovarian Neoplasms

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 1991

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1991Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients 
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ovarian Neoplasms
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Cancer Institute (NCI)Bethesda, United StatesSee the location
CompletedOne Study Center