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

Phase 2

Completed

• Conditions: Tumor; Cancer
• Interventions: Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

• Registration Number: NCT00113438
• Lead Sponsor: Mateon Therapeutics

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-06-07
• Study First Submitted QC: 2005-06-07
• Study First Posted: 2005-06-08
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2011-10
• Disposition First Submitted: 2011-10-28
• Disposition First Submitted QC: 2011-10-28
• Last Update Submitted: 2011-10-28
• Disposition First Posted: 2011-11-01
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 mg/m2 Combretastatin A-4 Phosphate	Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin	-
45 mg/m2 Combretastatin A-4 Phosphate	Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin	-

Primary Outcome Measures

Name	Time	Method
To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies	From first administration of study drug through approximately 30 days following last dose of study drug
To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies	from first study drug administration through end of study visit
To evaluate tumor response	From baseline through end of study visit
To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies	from screening through end of study visit

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States