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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | September 1991 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001272 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients |
| Official Title ICMJE | A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients |
| Brief Summary | 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. |
| 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. |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety Study |
| Condition ICMJE | Ovarian Neoplasms |
| Intervention ICMJE | Drug: taxol |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 60 |
| Completion Date | May 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Female |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001272 |
| Responsible Party | |
| Study ID Numbers ICMJE | 910232, 91-C-0232 |
| Study Sponsor ICMJE | National Cancer Institute (NCI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 1999 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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