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

May 12, 2014 updated by: Mateon Therapeutics

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]

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Belarus National Medical University
  • Bulgaria
      • Plodiv, Bulgaria
        • Regional Oncology Dispensary with Inpatient sector
      • Sofia, Bulgaria, 1504
        • Specialized Hospital for Active Treatment of Oncology
      • Sofia, Bulgaria
        • Universtiy Multiprofile Hospital, ISUI, Clinic of Oncotherapy
  • Egypt
      • Cairo, Egypt
        • University Hospital, Cairo
  • India
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India, 500063
        • Mediciti Hospital
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, Delhi, India, 110076
        • Apollo Cancer Institute
    • Karnataka
      • Bangalore, Karnataka, India
        • Kidwai Memorial Hospital
      • Manipal, Karnataka, India, 576119
        • Shirdi Sai Baba Cancer Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Centre
      • Pune, Maharashtra, India, 411011
        • Ruby Hall Clinic
    • Tamil Nadu
      • Vellore, Tamil Nadu, India
        • Christian Medial College
  • Israel
      • Tel-Aviv, Israel, 64239
        • Telaviv Sourasky Medical Center, Head and Neck Service Division of Oncology
  • Italy
      • Milano, Italy, 20133
        • Lo Studio E la Cura
      • Napoli, Italy
        • INT Napoli Fondazione Pascale
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto (IOV) - IRCCS
      • Pisa, Italy, 56124
        • Azienda Ospedaliero - Universitaria Pisana
  • Poland
      • Gliwice, Poland, 44-101
        • Zaklad Medyczny Nuklearnej i Endykrynologii
      • Warszawa, Poland, 02-781
        • Klinika Nowotworow Glowy i Szyji
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic
      • Craiova, Romania, 200535
        • SC Meditech SRL
      • Iasi, Romania, 700106
        • Centr of Medical Oncology
      • Sibiu, Romania, 550245
        • Clinical County Hospital Sibiu
      • Suceava, Romania, 720237
        • Emergency Clinical County Hospital "Sf. loan cel Nou"
  • Russian Federation
      • Saint Petersburg, Russian Federation, 198255
        • City Clinical Oncology Dispensary
  • Ukraine
      • Lvov, Ukraine
        • Regional Clinical Oncology Dispensary
    • Kiev
      • Lomonosova 33/43, Kiev, Ukraine, 03022
        • Ukrainian Academy of Medical Science
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital and Institute of Cancer Research
      • Southampton, United Kingdom
        • Southampton Hospital Oncology Centre
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 OYN
        • Beatson Oncology Centre, Gartnavel General Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University, School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Care Center at John Hopkins
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Otolaryngology Department
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Ireland Cancer Center/Division od Hematology
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anaplastic thyroid carcinoma histologically or cytologically confirmed by a pathology review
  • Refractory to or progressed during or after therapy, or relapsed within 6 months following initial combined modality therapy (usually including systemic chemotherapy and radiation) for regionally advanced disease
  • Systemic therapy is limited to one chemotherapy regimen that is clearly administered contiguously, (i.e., in an uninterrupted primary therapeutic approach)
  • Prior radiation: 3 weeks must have elapsed since radiation and disease must be present beyond radiation ports
  • Minimum of 3 weeks must have elapsed from the time of last chemotherapy prior to the first dose of study drug
  • Patients with bulky thyroid/neck masses and/or suspicion of airway obstruction must undergo screening (indirect and direct laryngoscopy) to ensure patency of the trachea/airway prior to study enrollment and treatment
  • ECOG Performance Score less than or equal to 2
  • Adequate bone marrow reserve as evidenced by absolute neutrophil count (ANC) greater than 1,500/microL, platelet count greater than 75,000/microL.
  • Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 mg/dL (less than 177 micromol/L)
  • Adequate hepatic function as evidenced by 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)
  • No clinically important sequelae from any prior surgery or radiotherapy.

Exclusion Criteria:

  • Tumors confined to the thyroid.
  • Clinically evident brain metastasis, including symptomatic involvement, evidence of cerebral edema by CT or MRI, radiographic evidence of progression of brain metastasis since definitive therapy, or continued requirement for corticosteroids
  • Patients who receive chemotherapy for metastatic disease after completion of a combined modality approach.
  • History of malignancies other than ATC except curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of less than 4.0 mg/dL or microg/L
  • Known hypersensitivity to CA4P, paclitaxel or carboplatin, or any of their components
  • Receiving concurrent investigational therapy or who have received investigational therapy for any indication within 28 days of the first scheduled day of dosing
  • Greater than Grade 2 peripheral neuropathy
  • History of prior cerebrovascular event, including transient ischemic attack
  • Uncontrolled hypertension (blood pressure greater than 150/100 mm Hg despite medication)
  • Symptomatic vascular disease (e.g. intermittent claudication)
  • History of unstable angina pectoris pattern, myocardial infarction (including non-Q wave MI) within the past 6 months, or NYHA Class III and IV congestive heart failure
  • History of torsade de pointes
  • Bradycardia (less than 60 b/m), heart block (excluding 1st degree block, being PR interval prolongation only), and congenital long QT syndrome
  • Any ventricular arrhythmias, or new ST segment elevation or depression or Q wave on ECG
  • Ejection fractions less than normal (i.e. less than 45%)
  • QTc prolongation greater than 450 ms
  • Requirement of any drugs known to prolong the QTc interval, including anti-arrhythmic medications
  • Potassium concentrations below 4.0 mEq/dL and magnesium concentrations below 1.8 mg/dL despite being on an electrolyte supplement
  • Requirement of any drugs known to prolong the QTc interval
  • History of solid organ transplant or bone marrow transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: CA4P + Carboplatin + paclitaxel
Six 21-day cycles: CA4P (60 mg/m2 on Days 1, 8, 15), carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2
Drug: CA4P
CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
Other Names:
  • Zybrestat
  • fosbretabulin
  • combretastatin
Active Comparator: Arm 2: Carboplatin + Paclitaxel
Six 21-day cycles of Carboplatin (AUC 6) + paclitaxel (200 mg/m2) given on Day 1
Drug: paclitaxel
200mg/m squared on Day 1
Other Names:
  • Taxol
  • Paxene
Drug: carboplatin
6 AUC on Day 1 following paclitaxel
Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From randomization to date last known alive
From randomization to date last known alive

Secondary Outcome Measures

Outcome Measure
Time Frame
To Determine Progression Free Survival
Time Frame: from randomization through end of study visit
from randomization through end of study visit
To Determine Percentage of 1 Year Survival
Time Frame: from randomization through end of study visit
from randomization through end of study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateon Therapeutics

Investigators

  • Principal Investigator: Julie A. Sosa, MD, FACS, Yale University School of Medicine, New Haven, CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXC4T4-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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