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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Tumor

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Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies

Outcome Time Frame:

From first administration of study drug through approximately 30 days following last dose of study drug

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CA4P-212

NCT ID:

NCT00113438

Start Date:

March 2005

Completion Date:

February 2007

Related Keywords:

  • Cancer
  • Tumor
  • cancer
  • tumor
  • imageable
  • CA4P
  • Combretastatin
  • Combretastatin A4 Phosphate
  • Combretastatin A-4 Phosphate
  • Carboplatin
  • Paclitaxel
  • carbo
  • taxol

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112