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Fludarabine Phosphate |
Fludara |
Clinical Trial: Safety and Effectiveness of Combretastatin A-4 Phosphate Combined with Chemotherapy in Advanced Solid Tumors
This study is currently recruiting patients.
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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 A4 Phosphate (CA4P) Drug: Carboplatin Drug: Paclitaxel | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: To assess safety and toxicity of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies; To gather preliminary data on the anti-tumor efficacy of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies; To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies; To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies
Expected Total Enrollment: 12
Expected Total Enrollment: 12
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 above, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00113438
Utah
Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States; Recruiting
Kylee Jackson, RN 801-585-0550 kylee.jackson@hci.utah.edu
More Information
Study ID Numbers: CA4P-212; HCI-13214
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 7, 2005
ClinicalTrials.gov Identifier: NCT00113438
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 7, 2005
ClinicalTrials.gov Identifier: NCT00113438
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Resources
- Fludara (Drug Digest)
- Fludarabine Phosphate (Drug Digest)
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