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Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer (FACT2)

This study has been withdrawn prior to enrollment.
(Expected inability to recruit study participants in a reasonable amount of time.)
Sponsor:
Information provided by (Responsible Party):
OXiGENE
ClinicalTrials.gov Identifier:
NCT01701349
First received: October 2, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC). The primary objective of the study is to determine overall survival. A maximum of 300 subjects will be recruited from approximately 75 multinational sites of which approximately 35 will be located in the United States.


Condition Intervention Phase
Anaplastic Thyroid Cancer
Drug: Fosbretabulin + paclitaxel + carboplatin
Drug: Placebo + paclitaxel + carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)

Resource links provided by NLM:


Further study details as provided by OXiGENE:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatin [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ] [ Designated as safety issue: Yes ]
  • Number of participants with 1-year survival [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Determine the proportion of subjects with measurable disease who have objective tumor response, by treatment [ Time Frame: Maximun length of study for each subject is 2 years from date of randomization ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosbretabulin + paclitaxel + carboplatin

Six 21 day cycles of:

Fosbretabulin (60 mg/m2) IV on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC 6) IV on Day 2

Drug: Fosbretabulin + paclitaxel + carboplatin
Fosbretabulin 200 mg/m2 IV infusion
Other Names:
  • Fosbretabulin
  • Combretastatin
  • Zybrestat
  • CA4P
Placebo Comparator: Placebo + paclitaxel + carboplatin

Six 21-day cycles of:

Placebo (formulated and packages to match fosbretabulin)on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC6) IV on Day 2

Drug: Placebo + paclitaxel + carboplatin
Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion
Other Names:
  • Paclitaxel
  • Carboplatin

Detailed Description:

The Treatment Plan followed for all subjects will consist of:

  • A Screening Visit within 14 days before study drug (fosbretabulin or placebo) administration
  • A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles (up to 6 cycles)
  • An End of Treatment Phase assessment
  • An End of Study Visit occurring 30 days after the last day of study drug administration, as able

After the last clinic visit, all subjects will be followed for survival by monthly phone calls, email, or in-person.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable, residual, recurrent or persistent ATC, histologically or cytologically confirmed
  • Prior cytotoxic therapeutic regimen as primary therapy for curative intent or prior targeted therapies (TKIs) are eligible (Prior taxane or platinum therapy is allowed)
  • Untreated ATC following biopsy, surgery for curative intent, palliation, or after radiation therapy has been considered or administered with or without radiosensitizing chemotherapy
  • Disease present on clinical exam (measurable or non-measurable)
  • Distant metastases (Stage IVC) only must have histologic confirmation of ATC either from the original primary lesion or a metastatic site
  • Neoadjuvant therapy with radiation and either radiosensitizing chemotherapy followed by surgery for curative intent, palliation, or biopsy are eligible if residual or persistent ATC is present
  • Subjects with tracheostomy are eligible
  • ECOG PS 2 or less
  • Adequate bone marrow, renal, and hepatic function, electrolytes WNL for the institution

Exclusion Criteria:

  • Disease that is able to be completely resected with negative microscopic margins and without any residual disease in the body
  • Active brain metastases, including symptomatic involvement, evidence of cerebral edema by prior CT or MRI, radiographic evidence of brain metastasis since definitive therapy, or continued requirement for corticosteroids for cerebral edema
  • History of malignancies other than ACT except prior lower grade thyroid malignancy, curatively treated basal cell carcinoma and in-situ melanoma of the skin, cervical intra-epithelial neoplasia,localized prostate cancer, in-situ carcinoma of the breast
  • Known intolerance or hypersensitivity to fosbretabulin, paclitaxel, carboplatin or any of their components
  • Receiving concurrent investigational therapy or have received investigational therapy for any indication within 28 days of the first scheduled day of dosing
  • Grade 3 or greater peripheral neuropathy
  • History of prior cerebrovascular event,including transient ischemic attack within the past 6 months
  • Uncontrolled hypertension defined as blood pressure >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) within the past 6 months, or NYHA Class III or IV congestive heart failure
  • History of torsade de pointes, ventricular tachycardia, ventricular fibrillation or congenital long QT syndrome.
  • Pathologic bradycardia (<60 b/m or heart block(excluding 1st degree block, consisting of PR interval prolongation only)
  • ECG findings of clinically significant ventricular arrhythmia, new ST segment elevation or depression, or new Q wave on ECG (PVCs are not excluded).
  • QTc interval 480 ms or more
  • Requirement of concurrent treatment with any drugs know to prolong the QTc interval, including anti-arrhythmic medications
  • Potassium and/or magnesium concentrations below normal range for the reference laboratory
  • History of solid organ or bone marrow transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701349

Sponsors and Collaborators
OXiGENE
Investigators
Principal Investigator: Marcia Brose, MD, PhD University of Pennsylvania, Philadelphia, PA 19104
Principal Investigator: Julie A Sosa, MD Yale University, New Haven, CT 06520
Principal Investigator: Lisa Licitra, MD Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
  More Information

Additional Information:
No publications provided

Responsible Party: OXiGENE
ClinicalTrials.gov Identifier: NCT01701349     History of Changes
Other Study ID Numbers: OX4317s
Study First Received: October 2, 2012
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OXiGENE:
ATC
Anaplastic Thyroid Cancer
Stage IVC Anaplastic Thyroid Cancer
Thyroid Cancer
Head and Neck Tumors

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Carboplatin
Fosbretabulin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014