AzTrials
AzTrials

Head and Neck CancerPhase 2NCT00060242

Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer

A Phase 2 study testing fosbretabulin disodium in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor. PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
fosbretabulin disodium
Type of treatment
Injection or infusion
How many people
26 participants
Where
3 sitesUnited States
Study dates
Feb 2003to Jan 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer, including 1 of the following:
  • Recurrent/regionally advanced disease no longer amenable to definitive curative surgery or radiotherapy
  • Untreated metastatic disease NOTE: *If original/diagnostic tumor blocks are unavailable, tumor must be accessible for pretreatment core needle biopsy
  • Must have relapsed or progressed during or after prior combined modality therapy (e.g., systemic chemotherapy and radiotherapy) for regionally advanced (but not metastatic) disease
  • Measurable or evaluable disease
  • Patent trachea and airway by screening direct and indirect laryngoscopy* NOTE: *For patients with bulky thyroid/neck masses and/or suspected airway obstruction
  • No active brain metastases, as evidenced by any of the following:
  • Symptomatic involvement
  • Cerebral edema by CT scan or MRI
  • Radiographic evidence of progression since definitive therapy
  • Continued requirement for corticosteroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 8.5 g/dL

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 3.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • LVEF at least 50% by MUGA
  • EKG normal
  • No evidence of prior myocardial infarction (e.g., significant Q waves), QTc greater than 450 msec, or other clinically significant abnormalities
  • No history of angina (even if controlled by medication)
  • No congestive heart failure
  • No uncontrolled atrial arrhythmias
  • No clinically significant arrhythmias, including any of the following:
  • Conduction abnormalities
  • 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 MUGA
  • No uncontrolled hypertension (blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic regardless of medication)
  • Patients with previous hypertension are allowed provided there is clinical documentation of controlled blood pressure for 2 months prior to study enrollment
  • No symptomatic peripheral vascular disease
  • No symptomatic cerebrovascular disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No grade 2 or greater preexisting motor or sensory peripheral neuropathy
  • No uncontrolled hypokalemia or hypomagnesemia
  • No concurrent serious infection
  • No other nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by study therapy
  • No psychiatric disorders or other conditions that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy
  • No concurrent immunotherapy
  • No concurrent prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy, except any of the following:
  • Gonadotropin-releasing hormone agonists for hormone-refractory prostate cancer
  • Hormone replacement therapy
  • Oral contraceptives
  • Megestrol for anorexia/cachexia

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy with progressive disease beyond radiation ports
  • No prior radiotherapy to more than 30% of the bone marrow
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • More than 4 weeks since prior major surgery

Other

  • At least 6 weeks since other prior therapy associated with delayed toxicity
  • No prior therapy for metastatic disease
  • No concurrent medication(s) known to prolong the QTc interval, unless medication(s) can be held for at least 72 hours before, during, and for at least 6 hours after study drug administration
  • No other concurrent investigational therapy
  • No other concurrent antineoplastic or cytotoxic therapy

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Phase II Trial Of Combretastatin A-4 Phosphate (CA4P) In Advanced Anaplastic Carcinoma Of The Thyroid

RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.

Read the detailed description

OBJECTIVES:

  • Determine the objective response rate of patients with advanced anaplastic thyroid cancer treated with combretastatin A4 phosphate.
  • Determine whether this drug alters the natural history of anaplastic thyroid cancer, in terms of doubling the median survival from 4-6 months to 12 months, in these patients.
  • Determine the safety profile of this drug in these patients.
  • Correlate clinical response with pretreatment tumor microvessel density and immature vessel staining, changes in sICAM-1 levels over the course of treatment, and pharmacokinetic parameters in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18-24 months.

Being tested
fosbretabulin disodium
Keywords
anaplastic thyroid cancer, recurrent thyroid cancer
Medical subject headings
Head and Neck Neoplasms, Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fosbretabulin disodiumDrug

    Also called Combretastatin A4 phosphate

    Combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median survival

    Measured: every 8 weeks

Secondary outcomes (1)
  1. Objective disease response

    Measured: every 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionFeb 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060242
Sponsor's protocol ID
ICC2302
Other IDs
P30CA043703, CASE-CWRU-ICC-2302
Status last verified
Jun 2010
First submitted
6 May 2003
Last updated
11 Jun 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Mooney CJ, Nagaiah G, Fu P, Wasman JK, Cooney MM, Savvides PS, Bokar JA, Dowlati A, Wang D, Agarwala SS, Flick SM, Hartman PH, Ortiz JD, Lavertu PN, Remick SC. A phase II trial of fosbretabulin in advanced anaplastic thyroid carcinoma and correlation of baseline serum-soluble intracellular adhesion molecule-1 with outcome. Thyroid. 2009 Mar;19(3):233-40. doi: 10.1089/thy.2008.0321.

    PubMed 19265494
  • Giri P, Batra PJ, Kumari A, Hura N, Adhikary R, Acharya A, Guchhait SK, Panda D. Development of QTMP: A promising anticancer agent through NP-Privileged Motif-Driven structural modulation. Bioorg Med Chem. 2023 Nov 15;95:117489. doi: 10.1016/j.bmc.2023.117489. Epub 2023 Oct 5.

    PubMed 37816266

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fosbretabulin disodium in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median survival (time frame: every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060242, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.

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