- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001272
A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910232
- 91-C-0232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
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Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
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Medical University of LublinCompletedOvarian Cancer | Unexplained Infertility | Borderline Ovarian Tumors | Benign Ovarian TumorPoland
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