Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer
Information source: OXiGENE
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anaplastic Thyroid Cancer
Intervention: Fosbretabulin + paclitaxel + carboplatin (Drug); Placebo + paclitaxel + carboplatin (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: OXiGENE Official(s) and/or principal investigator(s): Marcia Brose, MD, PhD, Principal Investigator, Affiliation: University of Pennsylvania, Philadelphia, PA 19104 Julie A Sosa, MD, Principal Investigator, Affiliation: Yale University, New Haven, CT 06520 Lisa Licitra, MD, Principal Investigator, Affiliation: Instituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milan, Italy
Summary
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Overall survival
Secondary outcome: Number of adverse events of the combination of fosbretabulin + paclitaxel + carboplatinNumber of participants with 1-year survival
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Corporate website Thyroid Cancer Survivors' Association, Inc.
Starting date: March 2015
Last updated: April 30, 2014
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