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| Sponsor: | OXiGENE |
|---|---|
| Information provided by (Responsible Party): | OXiGENE |
| ClinicalTrials.gov Identifier: | NCT00507429 |
Purpose
The purpose of the study is to determine the safety and efficacy of combretastatin combined with paclitaxel and carboplatin in the treatment of anaplastic thyroid cancer (ATC).
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Thyroid Cancer |
Drug: combretastatin A-4 phosphate (CA4P) Drug: paclitaxel Drug: carboplatin |
Phase II Phase III |
| 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 Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin in Comparison With Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma |
| Enrollment: | 80 |
| Study Start Date: | July 2007 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CA4P + carboplatin + paclitaxel
|
Drug: combretastatin A-4 phosphate (CA4P)
CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
Other Names:
|
|
Active Comparator: 2
Carboplatin + paclitaxel
|
Drug: paclitaxel
200mg/m squared on Day 1
Other Names:
Drug: carboplatin
6 AUC on Day 1 following paclitaxel
Other Name: Paraplatin
|
Anaplastic thyroid carcinoma (ATC) is a high-grade neoplasm, characterized by an aggressive clinical course with brief survival, and refractoriness to currently available local and systemic modalities of treatment. There is no standard therapy for ATC, and no randomized comparative trials have been known to be conducted in this disease. One potential strategy is to combine the anti-tumor activity of the vascular disrupting agent combretastatin with conventional cytotoxic agents. This study will compare the overall survival of ATC patients treated with the triplet combination of combretastatin, paclitaxel, and carboplatin compared with the doublet treatment of paclitaxel and carboplatin.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Absolute neutrophil count (ANC) greater than 1,500/microL. Platelet count greater than 75,000/microL.
Serum total bilirubin less than 2X greater than the upper limit of normal (ULN) (less than3X ULN in patients with liver metastases).
AST (aspartate aminotransferase)/ALT (alanine aminotransferase) less than or equal to 3X the ULN for the local reference lab (less than or equal to 5X the ULN for patients with liver metastases).
Exclusion Criteria:
Contacts and Locations
Show 41 Study Locations
More Information
| Responsible Party: | OXiGENE |
| ClinicalTrials.gov Identifier: | NCT00507429 History of Changes |
| Other Study ID Numbers: | OXC4T4-302 |
| Study First Received: | July 25, 2007 |
| Last Updated: | January 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
thyroid neoplasms thyroid cancer thyroid carcinoma |
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases 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 |