Clinical trial · Interventional
Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
Phase II Trial of Combined Modality Combretastatin A-4 Phosphate (CA4P)-Based Therapy for Patients With Newly Diagnosed Anaplastic Thyroid Cancer [Induction Chemotherapy With Doxorubicin/Cisplatin; Combined Modality Therapy With CA4P and Radiation; Followed by 2 Cycles of CA4P Consolidation]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combretastatin A4 phosphate may stop the growth of cancer by stopping blood flow to the tumor. Combining doxorubicin and cisplatin with radiation therapy and combretastatin A4 phosphate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving induction chemotherapy using doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate works in treating patients with newly diagnosed regionally advanced anaplastic thyroid cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fosbretabulin disodium | Drug | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median survival
- timeFrame
- at months 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 33, and 36
Secondary outcomes (1)
- measure
- Objective disease response
- timeFrame
- at the end of induction, combined modality therapy, and consolidation therapy, at 2 months after completion of consolidation therapy, at 2 month intervals during year 1, and then 3 month intervals during years 2 and 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following:
* Regionally advanced disease
* Confined to the neck and/or superior mediastinum (i.e., above the level of the carina)
* Measurable or evaluable\* disease
* Completely resected disease without measurable or evaluable disease NOTE: \*At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed
* Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry
* Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy
* Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction
* No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases
* Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8.5 g/dL
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 3.5 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* LVEF ≥ 50% by echocardiogram
* EKG normal
* No prior angina
* No prior myocardial infarction (e.g., significant Q waves), QTc \> 450 msec, or other clinically significant abnormalities on ECG
* No congestive heart failure
* No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following:
* Conduction abnormality
* Nodal junctional arrhythmias and dysrhythmias
* Sinus bradycardia or tachycardia
* Supraventricular arrhythmias
* Atrial fibrillation or flutter
* Syncope or vasovagal episodes
* No significant heart wall abnormality or heart muscle damage by echocardiogram
* No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
* Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry
* No symptomatic peripheral vascular disease or cerebrovascular disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled hypokalemia or hypomagnesemia
* No concurrent serious infection
* No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy
* No grade 2 or greater pre-existing motor or sensory peripheral neuropathy
* No psychiatric disorder or other condition that would preclude study compliance
* No conditions associated with QTc prolongation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic therapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy, except for the following:
* Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer
* Hormone replacement therapy
* Oral contraceptives
* Megestrol for anorexia/cachexia
Radiotherapy
* No prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases
* At least 1 week but no more than 8 weeks since prior surgery and recovered
Other
* No other concurrent cytotoxic therapy
* No other concurrent antineoplastic therapy
* No other concurrent investigational therapy
* No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment courseReferences
Publications (0)
Data not yet available