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

M

Mateon Therapeutics

Status and phase

Completed
Phase 2

Conditions

Tumor
Cancer

Treatments

Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113438
CA4P-212
HCI-13214 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

45 mg/m2 Combretastatin A-4 Phosphate
Experimental group
Treatment:
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
60 mg/m2 Combretastatin A-4 Phosphate
Experimental group
Treatment:
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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