Conditions: Anaplastic Thyroid Cancer
Keywords: thyroid neoplasms thyroid cancer thyroid carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Six 21-day cycles: CA4P (60 mg/m2 on Days 1, 8, 15), carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2 arm 2: Six 21-day cycles of Carboplatin (AUC 6) + paclitaxel (200 mg/m2) given on Day 1

Interventions: intervention 1: CA4P intervention 2: paclitaxel intervention 3: carboplatin
Intervention descriptions: intervention 1: CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles intervention 2: 200mg/m squared on Day 1 intervention 3: 6 AUC on Day 1 following paclitaxel

Protocol document: