Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer

NCT00485485 | Completed Phase 2 Results

• 1 other identifier: 2006-0362
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Secondary Objectives:
• To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
• To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R).
• To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
• To assess the rate of survival.

Conditions

Head and Neck Cancer; Squamous Cell Cancer

Keywords

Head and Neck Cancer; Squamous Cell Cancer; Imatinib Mesylate; Gleevec; Imatinib; STI571; Docetaxel; Taxotere

Outcome Measures

Primary Outcomes (1)

• Participant Response Rate

  Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.

  At 6 weeks reconfirmed 6 weeks later

Study Arms (1)

Imatinib Mesylate + Docetaxel

EXPERIMENTAL

Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks

Drug: Imatinib Mesylate; Drug: Docetaxel

Interventions

Imatinib Mesylate DRUG

400 mg by mouth daily

Also known as: Gleevec, Imatinib, STI571

Imatinib Mesylate + Docetaxel

Docetaxel DRUG

60 mg/m\^2 by vein (IV) over 1 hour every 3 weeks

Also known as: Taxotere

Imatinib Mesylate + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A written, voluntary informed consent form must be completed prior to beginning any study procedure.
• Patients \>/= 18 years of age.
• Histologically documented diagnosis of head and neck squamous cell cancer
• At least one measurable site of disease and can be assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
• Performance status 0-2 (Eastern Cooperative Oncology Group, ECOG)
• Patients must have adequate hepatic, renal, and bone marrow function, defined as the following: (1) total bilirubin \< 1.5 \* Upper Limits of Normal (ULN); (2) aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 2.5 \* ULN; (3) creatinine \< 1.5 \* ULN; (4) ANC \> 1.5 \* 10\^9/L; (5) platelets \> 100 \* 10\^9/L.
• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control (i.e. condoms, diaphragm) throughout the study and for up to 3 months following discontinuation of study drug.
• Patients who have not been treated for recurrent or metastatic head and neck squamous cell carcinomas (HNSCC) (i.e. Patients who have been treated with chemotherapy for induction/adjuvant or concurrent therapy with radiation in the setting of definitive treatment but have now developed recurrent or metastatic disease are eligible).

You may not qualify if:

• Prior exposure to docetaxel or imatinib mesylate.
• Patient has received any other investigational agents within 30 days of first day of study drug dosing.
• Patients with myocardial infarction within the past 6 months or New York Heart Association class 3 or 4 congestive heart failure.
• Female patients who are pregnant or breast-feeding.
• Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).
• Patient has unstable brain metastasis. Unstable brain metastasis is defined as patients on steroid medication to control symptoms or patient with motor neurologic compromise due to brain metastasis. Patients with treated brain metastasis are eligible if they are \> 6 weeks out from therapy and off all steroid medication.
• Patient has known chronic liver disease (i.e., chronic active hepatitis or cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV patients are at much greater risk of infection when receiving highly myelosuppressive agents (docetaxel and imatinib) and for safety reasons are not eligible for this trial.
• Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
• Patient previously received radiotherapy to \>/= 25 % of the bone marrow
• Patient had a major surgery within 2 weeks prior to study entry.
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
• Patients must agree not to use herbal remedies or other over-the-counter biologics (i.e. shark cartilage)
• History of hypersensitivity to docetaxel or other taxane therapy.
• History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms, Squamous Cell

Interventions

Imatinib Mesylate; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Limitations and Caveats

Study was closed to enrollment early due to low enrollment. Study enrolled 7 participants over approximately 2 years with a planned enrollment of up to 58.

Results Point of Contact

• Title: Anne Tsao, M.D. / Associate Professor
• Organization: UT MD Anderson Cancer Center

mejprice@mdanderson.org

713-792-6363

Study Officials

• Anne S. Tsao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: August 29, 2011

Record last verified: 2012-08

Locations

US (1)