Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mateon Therapeutics
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Combretastatin; Fosbretabulin; Paclitaxel

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.