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
18 Years
N/A
Both
Cancer, Tumor
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 Institute | Salt Lake City, Utah 84112 |
