Anaplastic Thyroid CancerPhase 2/3FACTNCT00507429
Study of Combretastatin and Paclitaxel/Carboplatin in the Treatment of Anaplastic Thyroid Cancer
A Phase 2/3 study testing CA4P, paclitaxel and carboplatin in people with Anaplastic Thyroid Cancer, run by Mateon Therapeutics at 41 sites in 12 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer
- What is being tested?
- CA4P, paclitaxel and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 41 sitesin 12 countries
- Study dates
- Aug 2007to Nov 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
41 sites in 12 countries.
41 sites in 12 countries
United States10 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Sidney Kimmel Comprehensive Cancer Care Center at John Hopkins
Baltimore, Maryland, 21231
Ireland Cancer Center/Division od Hematology
Cleveland, Ohio, 44106
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Minnesota Otolaryngology Department
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
Yale University, School of Medicine
New Haven, Connecticut, 06520
Oregon Health and Science University
Portland, Oregon, 97239
India8 sites
Kidwai Memorial Hospital
Bangalore, Karnataka
Mediciti Hospital
Hyderabaad, Andhra Pradesh, 500063
Shirdi Sai Baba Cancer Hospital
Manipal, Karnataka, 576119
Tata Memorial Centre
Mumbai, Maharashtra, 400012
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Apollo Cancer Institute
New Delhi, National Capital Territory of Delhi, 110076
Ruby Hall Clinic
Pune, Maharashtra, 411011
Christian Medial College
Vellore, Tamil Nadu
Romania5 sites
Institutul Oncologic
Cluj-Napoca, 400015
SC Meditech SRL
Craiova, 200535
Centr of Medical Oncology
Iași, 700106
Clinical County Hospital Sibiu
Sibiu, 550245
Emergency Clinical County Hospital "Sf. loan cel Nou"
Suceava, 720237
Italy4 sites
Lo Studio E la Cura
Milan, 20133
INT Napoli Fondazione Pascale
Naples
Istituto Oncologico Veneto (IOV) - IRCCS
Padova, 35128
Azienda Ospedaliero - Universitaria Pisana
Pisa, 56124
Bulgaria3 sites
Regional Oncology Dispensary with Inpatient Sector
Plodiv
Specialized Hospital for Active Treatment of Oncology
Sofia, 1504
Universtiy Multiprofile Hospital, ISUI, Clinic of Oncotherapy
Sofia
United Kingdom3 sites
Beatson Oncology Centre, Gartnavel General Hospital
Glasgow, Scotland, G12 OYN
Royal Marsden Hospital and Institute of Cancer Research
London, SW3 6JJ
Southampton Hospital Oncology Centre
Southampton
Poland2 sites
Zaklad Medyczny Nuklearnej i Endykrynologii
Gliwice, 44-101
Klinika Nowotworow Glowy i Szyji
Warsaw, 02-781
Ukraine2 sites
Ukrainian Academy of Medical Science
Lomonosova 33/43, Kiev, 03022
Regional Clinical Oncology Dispensary
Lviv
Israel1 site
Telaviv Sourasky Medical Center, Head and Neck Service Division of Oncology
Tel Aviv, 64239
About this study
Official title: 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).
Read the 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.
- Conditions
- Anaplastic Thyroid Cancer
- Being tested
- CA4P, paclitaxel, carboplatin
- Keywords
- thyroid neoplasms, thyroid cancer, thyroid carcinoma
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA4PDrug
Also called combretastatin, fosbretabulin, Zybrestat
CA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles
paclitaxelDrug
Also called Taxol, Paxene
200mg/m squared on Day 1
carboplatinDrug
Also called Paraplatin
6 AUC on Day 1 following paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CA4P + Carboplatin + paclitaxel | Experimental | Six 21-day cycles: CA4P (60 mg/m2 on Days 1, 8, 15), carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2 Receives: Drug: CA4P |
| Arm 2: Carboplatin + Paclitaxel | Active comparator | Six 21-day cycles of Carboplatin (AUC 6) + paclitaxel (200 mg/m2) given on Day 1 Receives: Drug: paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From randomization to date last known alive
Secondary outcomes (2)
To Determine Progression Free Survival
Measured: from randomization through end of study visit
To Determine Percentage of 1 Year Survival
Measured: from randomization through end of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2011
- Study completionNov 2011
Why it stopped: Low rate of subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie A. Sosa, MD, FACS, Principal investigator, Yale University School of Medicine, New Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507429
- Sponsor's protocol ID
- OXC4T4-302
- Acronym
- FACT
- Status last verified
- Feb 2014
- First submitted
- 25 Jul 2007
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yeung SC, She M, Yang H, Pan J, Sun L, Chaplin D. Combination chemotherapy including combretastatin A4 phosphate and paclitaxel is effective against anaplastic thyroid cancer in a nude mouse xenograft model. J Clin Endocrinol Metab. 2007 Aug;92(8):2902-9. doi: 10.1210/jc.2007-0027. Epub 2007 Jun 5.
PubMed 17550961Patel KN, Shaha AR. Poorly differentiated and anaplastic thyroid cancer. Cancer Control. 2006 Apr;13(2):119-28. doi: 10.1177/107327480601300206.
PubMed 16735986Ain KB. Anaplastic thyroid carcinoma: behavior, biology, and therapeutic approaches. Thyroid. 1998 Aug;8(8):715-26. doi: 10.1089/thy.1998.8.715.
PubMed 9737368De Crevoisier R, Baudin E, Bachelot A, Leboulleux S, Travagli JP, Caillou B, Schlumberger M. Combined treatment of anaplastic thyroid carcinoma with surgery, chemotherapy, and hyperfractionated accelerated external radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1137-43. doi: 10.1016/j.ijrobp.2004.05.032.
PubMed 15519785Siemann DW, Chaplin DJ, Horsman MR. Vascular-targeting therapies for treatment of malignant disease. Cancer. 2004 Jun 15;100(12):2491-9. doi: 10.1002/cncr.20299.
PubMed 15197790Horsman MR, Siemann DW. Pathophysiologic effects of vascular-targeting agents and the implications for combination with conventional therapies. Cancer Res. 2006 Dec 15;66(24):11520-39. doi: 10.1158/0008-5472.CAN-06-2848.
PubMed 17178843Cooney MM, Savvides P, Agarwala SS, Wang D, Flick S, Bergant S, Bhatka S,Fu P, Subbiah V, Lavertu P, Ortiz J, and Remick S. Phase II study of combretastatin A4 phosphate (CA4P) in patients with advanced anaplastic thyroid carcinoma. J Clinical Oncology, 2006 Vol. 24, 5580.
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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]
- ClinicalTrials.gov ID
- NCT00507429
- Acronym / sponsor ID
- FACT / OXC4T4-302
- Conditions
- Anaplastic Thyroid Cancer
- Keywords
- thyroid neoplasms, thyroid cancer, thyroid carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of subject accrual
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CA4P + Carboplatin + paclitaxel | Experimental | Drug: CA4PSix 21-day cycles: CA4P (60 mg/m2 on Days 1, 8, 15), carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2 |
| Arm 2: Carboplatin + Paclitaxel | Active comparator | Drug: paclitaxel, Drug: carboplatinSix 21-day cycles of Carboplatin (AUC 6) + paclitaxel (200 mg/m2) given on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA4PAlso: combretastatin, fosbretabulin, ZybrestatCA4P 60mg/m squared for Days 1, 8, 15 for 6 cycles | Drug | Arm 1: CA4P + Carboplatin + paclitaxel |
| paclitaxelAlso: Taxol, Paxene200mg/m squared on Day 1 | Drug | Arm 2: Carboplatin + Paclitaxel |
| carboplatinAlso: Paraplatin6 AUC on Day 1 following paclitaxel | Drug | Arm 2: Carboplatin + Paclitaxel |
Primary outcome
Overall Survival
Time frame: From randomization to date last known alive
2 secondary outcomes
To Determine Progression Free Survival
Time frame: from randomization through end of study visit
To Determine Percentage of 1 Year Survival
Time frame: from randomization through end of study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17550961Yeung SC, She M, Yang H, Pan J, Sun L, Chaplin D. Combination chemotherapy including combretastatin A4 phosphate and paclitaxel is effective against anaplastic thyroid cancer in a nude mouse xenograft model. J Clin Endocrinol Metab. 2007 Aug;92(8):2902-9. doi: 10.1210/jc.2007-0027. Epub 2007 Jun 5.
- Background: PubMed 16735986Patel KN, Shaha AR. Poorly differentiated and anaplastic thyroid cancer. Cancer Control. 2006 Apr;13(2):119-28. doi: 10.1177/107327480601300206.
- Background: PubMed 9737368Ain KB. Anaplastic thyroid carcinoma: behavior, biology, and therapeutic approaches. Thyroid. 1998 Aug;8(8):715-26. doi: 10.1089/thy.1998.8.715.
- Background: PubMed 15519785De Crevoisier R, Baudin E, Bachelot A, Leboulleux S, Travagli JP, Caillou B, Schlumberger M. Combined treatment of anaplastic thyroid carcinoma with surgery, chemotherapy, and hyperfractionated accelerated external radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Nov 15;60(4):1137-43. doi: 10.1016/j.ijrobp.2004.05.032.
- Background: PubMed 15197790Siemann DW, Chaplin DJ, Horsman MR. Vascular-targeting therapies for treatment of malignant disease. Cancer. 2004 Jun 15;100(12):2491-9. doi: 10.1002/cncr.20299.
- Background: PubMed 17178843Horsman MR, Siemann DW. Pathophysiologic effects of vascular-targeting agents and the implications for combination with conventional therapies. Cancer Res. 2006 Dec 15;66(24):11520-39. doi: 10.1158/0008-5472.CAN-06-2848.
- BackgroundCooney MM, Savvides P, Agarwala SS, Wang D, Flick S, Bergant S, Bhatka S,Fu P, Subbiah V, Lavertu P, Ortiz J, and Remick S. Phase II study of combretastatin A4 phosphate (CA4P) in patients with advanced anaplastic thyroid carcinoma. J Clinical Oncology, 2006 Vol. 24, 5580.
- Derived from this study: PubMed 37816266Giri 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.
- Link to Thyroid Cancer Survivors websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A. Sosa, MD, FACS principal investigator
Yale University School of Medicine, New Haven, CT
41 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CA4P, paclitaxel and carboplatin in people with Anaplastic Thyroid Cancer, run by Mateon Therapeutics at 41 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. 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: stopped early, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, India, Romania, Italy, Bulgaria and 7 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: From randomization to date last known alive). 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 NCT00507429, which also lists 8 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 9 Jun 2014.