Imatinib Mesylate and Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

NCT01083589 | Completed Phase 2

• 1 other identifier: 2004-0726
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn how effective the combination of the drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell lung cancer (NSCLC). The safety and tolerability of this drug combination will also be studied.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung Cancer; Metastatic NSCLC; Tumor; Imatinib Mesylate; Gleevec; Docetaxel; Taxotere

Outcome Measures

Primary Outcomes (1)

• Patient Response Rate

  Response rate to new regimen defined as the percentage of complete or partial response within the total number of patients treated. Treatment response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

  Baseline and with each 3 week cycle

Study Arms (1)

Imatinib Mesylate + Docetaxel

EXPERIMENTAL

Imatinib Mesylate (Gleevec) Oral 400 mg daily + Docetaxel (Taxotere) 60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.

Drug: Imatinib Mesylate; Drug: Docetaxel

Interventions

Imatinib Mesylate DRUG

Oral 400 mg daily

Also known as: Imatinib, Gleevec, STI571, NSC-716051

Imatinib Mesylate + Docetaxel

Docetaxel DRUG

60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.

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:

• An written, voluntary informed consent form must be completed prior to beginning any study procedure.
• Patients \>/= 18 years of age.
• Histologically documented diagnosis of non-small cell lung cancer.
• At least one measurable site of disease that is amenable to biopsy. Lesion must be at least 20 mm in the longest diameter by spiral computed tomography (CT) or 20 mm with conventional techniques according to RECIST. Lesion must not have been previously irradiated.
• Performance status 0-1 (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 limit of normal (ULN); (2) serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 2.5 \* UNL; (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 throughout the study and for up to 3 months following discontinuation of study drug.
• Patients who have received one prior systemic chemotherapy treatment (not including biologic agents e.g. gefitinib, lonafarnib).
• Patients who were originally diagnosed with earlier stage Non-small-cell lung carcinoma (NSCLC) \& were treated with curative intent (i.e. pts who have received induction chemotherapy (platinum-based doublet) prior to definitive radiation or surgery) but then develop recurrent or metastatic disease \& are then treated with a platinum-based doublet for frontline metastatic therapy are still eligible for this study. This is as long as they have not been exposed to docetaxel during any point of their therapy. Once patients have been diagnosed with metastatic or recurrent disease, they may only have received one platinum-based therapy.

You may not qualify if:

• Patient has received any other investigational agents within 30 days of first day of study drug dosing.
• Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
• Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
• 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).
• Patient has a known untreated or unstable brain metastasis.
• Patient has known chronic liver disease (i.e., chronic active hepatitis, and 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)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasms

Interventions

Imatinib Mesylate; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

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

Study Officials

• Anne S. Tsao, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: July 1, 2011
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)