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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|ClinicalTrials.gov Identifier: NCT00001272|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: taxol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Official Title:||A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients|
|Study Start Date :||September 1991|
|Study Completion Date :||May 2000|
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001272
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|
|Other Study ID Numbers:||
|First Posted:||December 10, 2002 Key Record Dates|
|Last Update Posted:||March 4, 2008|
|Last Verified:||June 1999|
Hematopoietic Growth Factor
Endocrine Gland Neoplasms
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Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases