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

October 28, 2011 updated by: Mateon Therapeutics

A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 45 mg/m2 Combretastatin A-4 Phosphate
Drug: 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.
Other Names:
  • CA4P
  • carboplatin
  • paclitaxel
  • fosbretabulin
Experimental: 60 mg/m2 Combretastatin A-4 Phosphate
Drug: 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.
Other Names:
  • CA4P
  • carboplatin
  • paclitaxel
  • fosbretabulin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

June 7, 2005

First Submitted That Met QC Criteria

June 7, 2005

First Posted (Estimate)

June 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA4P-212
  • HCI-13214 (Other Identifier: Huntsman Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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