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

NCT ID: NCT00113438

Last Updated: 2011-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-02-28

Brief 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.

Detailed Description

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.

Conditions

Cancer; Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

45 mg/m2 Combretastatin A-4 Phosphate

Group Type: EXPERIMENTAL

Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Intervention Type: DRUG

Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.

60 mg/m2 Combretastatin A-4 Phosphate

Group Type: EXPERIMENTAL

Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Intervention Type: DRUG

Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.

Interventions

Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.

Intervention Type: DRUG

Other Intervention Names

CA4P; fosbretabulin; paclitaxel; carboplatin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mateon Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HCI-13214

Identifier Type: OTHER

Identifier Source: secondary_id

CA4P-212

Identifier Type: -

Identifier Source: org_study_id