Clinical trial NCT00113438: Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Tumor
Keywords: cancer
tumor
imageable
CA4P
Combretastatin
Combretastatin A4 Phosphate
Combretastatin A-4 Phosphate
Carboplatin
Paclitaxel
carbo
taxol
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-06-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
timeFrame: From first administration of study drug through approximately 30 days following last dose of study drug
measure: To evaluate tumor response
timeFrame: From baseline through end of study visit
measure: To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies
timeFrame: from first study drug administration through end of study visit
measure: To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies
timeFrame: from screening through end of study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References: