Salt Lake City,
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.
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.
- 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.
- Uncontrolled brain metastasis.
- Significant cardiac abnormalities.
- Prior radiotherapy at the tumor site.
- Symptomatic peripheral vascular or cerebrovascular disease.
- Uncontrolled hypertension.