Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Thyroid Carcinoma, Anaplastic

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Fosbretabulin

Combretastatin

Tubulin Modulators

Antimitotic Agents

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

Six 21-day cycles of Carboplatin (AUC 6) + paclitaxel (200 mg/m2) given on Day 1

CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles

CA4P

paclitaxel

carboplatin

Julie A. Sosa, MD, FACS

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).

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.

Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer

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 [FACT]

Mateon Therapeutics

The median duration of overall follow-up was 4.5 mos, with a range of 0.1 to 35.5 mos. The median follow-up for Arm 1 subjects was 5.1 mos compared to 3.9 mos for Arm 2 subjects. Median follow-up for the study drug treatment periods (exposure to study drugs) was 2.9 mos (range = 0.1-22.1 mos) for Arm 1 versus 2.8 mos (range 0.2-6.9 mos) Arm 2.

Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2

Arm 1, Active: CA4P + Carboplatin + Paclitaxel

Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1

Arm 2, Comparator: Carboplatin + Paclitaxel

Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.

On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.

Arm 2, Control: Carboplatin + Paclitaxel

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Belarus

United States

Poland

Ukraine

Romania

Russian Federation

Bulgaria

Israel

Italy

United Kingdom

India

Region of Enrollment

The study was to enroll 180 subjects. Enrollment was terminated early due to low accrual rate. Eighty subjects were enrolled.

Peter Langecker, MD, PhD

All randomized subjects (the Intent-to-treat population) included in the analysis

Overall Survival

To Determine Progression Free Survival

To Determine Percentage of 1 Year Survival

Treatment Phase

Maintenance Phase

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.

Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

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.

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.

Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer	NCT00507429	Anaplastic Thyr...	CA4P paclitaxel carboplatin	18 Years -	Mateon Therapeutics
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors	NCT00113438	Cancer Tumor	Combretastatin ...	18 Years -	Mateon Therapeutics
Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer	NCT00507429	Anaplastic Thyr...	CA4P paclitaxel carboplatin	18 Years -	Mateon Therapeutics
Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer	NCT00507429	Anaplastic Thyr...	CA4P paclitaxel carboplatin	18 Years -	Mateon Therapeutics
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors	NCT00113438	Cancer Tumor	Combretastatin ...	18 Years -	Mateon Therapeutics

Spots Global Cancer Trial Database for ca4p

Every month we try and update this database with for ca4p cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ca4p

Every month we try and update this database with for ca4p cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ca4p cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.