Expired Study
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Salt Lake City, Utah 84112


Purpose:

This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.


Study summary:

This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate (CA4P) combined with carboplatin and paclitaxel. Treatment is for a maximum of 6 consecutive 21-day cycles. Patients are randomized onto one of two CA4P dosing arms (45 or 63 mg/m2). CA4P is administered on days 1, 8 and 15 of each cycle. Carboplatin and paclitaxel (AUC 6 and 200 mg/m2, respectively) are administered on day 2 of each cycle. At least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following treatment with CA4P.


Criteria:

Inclusion Criteria: - Advanced malignancy where treatment with carboplatin and paclitaxel is warranted. - Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment. - Radiologically measurable disease to meet MRI perfusion criteria. - ECOG performance status less than or equal to 1. - Life expectancy greater than 12 weeks. - Normal ejection fraction. Exclusion Criteria: - Uncontrolled brain metastasis. - Significant cardiac abnormalities. - Prior radiotherapy at the tumor site. - Symptomatic peripheral vascular or cerebrovascular disease. - Uncontrolled hypertension.


NCT ID:

NCT00113438


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84112
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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