Cancer, Tumor
Conditions
Keywords
cancer, tumor, imageable, CA4P, Combretastatin, Combretastatin A4 Phosphate, Combretastatin A-4 Phosphate, Carboplatin, Paclitaxel, carbo, taxol
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.
Interventions
DRUGCombretastatin 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.
Sponsors
Mateon Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies | From first administration of study drug through approximately 30 days following last dose of study drug |
| To evaluate tumor response | 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 | 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 | from screening through end of study visit |
Countries
United States
Outcome results
None listed