Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Tumor |
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies [ Time Frame: From first administration of study drug through approximately 30 days following last dose of study drug ] [ Designated as safety issue: Yes ]
- To evaluate tumor response [ Time Frame: From baseline through end of study visit ] [ Designated as safety issue: No ]
- To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies [ Time Frame: from first study drug administration through end of study visit ] [ Designated as safety issue: Yes ]
- To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies [ Time Frame: from screening through end of study visit ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | March 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 45 mg/m2 Combretastatin A-4 Phosphate |
Drug: Combretastatin 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.
Other Names:
|
| Experimental: 60 mg/m2 Combretastatin A-4 Phosphate |
Drug: Combretastatin 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.
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | OXiGENE |
| ClinicalTrials.gov Identifier: | NCT00113438 History of Changes |
| Other Study ID Numbers: | CA4P-212, HCI-13214 |
| Study First Received: | June 7, 2005 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by OXiGENE:
|
cancer tumor imageable CA4P Combretastatin Combretastatin A4 Phosphate |
Combretastatin A-4 Phosphate Carboplatin Paclitaxel carbo taxol |
Additional relevant MeSH terms:
|
Combretastatin Paclitaxel Combretastatin A-4 Carboplatin Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013