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BATTLE Program: Tarceva and Targretin in Patients With NSCLC
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
First Received: December 12, 2006   Last Updated: December 15, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Department of Defense
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00411632
  Purpose

Primary Objective:

  • The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.

Secondary Objectives:

  • Determine the overall response rate
  • Determine the overall survival
  • Determine the time to disease progression
  • Assess the safety/toxicity of the study treatment
  • Assess the biomarker modulation in the tumor tissue from the treatment
  • Assess plasma and intra-tumor concentrations of study treatment

Condition Intervention Phase
Lung Cancer
Drug: Bexarotene
Drug: Erlotinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Bexarotene Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To evaluate the effectiveness of Tarceva (OSI-774, erlotinib hydrochloride) in combination with Targretin (bexarotene) in treating NSCLC. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the safety of this treatment, as well as the treatment's effect on different cells in the body and the participants' overall response. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: November 2006
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Bexarotene + Erlotinib
Drug: Bexarotene
400 mg/m^2 by mouth daily x 28 Days
Drug: Erlotinib
150 mg by mouth daily x 28 Days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
  2. The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).
  3. The patient has uni-dimensionally measurable NSCLC.
  4. Karnofsky performance status >/= 60 or ECOG performance status 0-2
  5. The patient has biopsy accessible tumor.
  6. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.
  7. The patient has adequate hepatic function as defined by a total bilirubin level </= 1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT </= 2.5 X the upper limit of normal.
  8. The patient has adequate renal function as defined by a serum creatinine level </= 1.5 mg/dL or a calculated creatinine clearance of >/= 60cc/minute.
  9. The patient has PT < 1.5 x upper limit of normal
  10. If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation if treated with radiation and not have used steroids for at least 1 week.
  11. The patient is >/= 18 years of age.
  12. The patient has signed informed consent.
  13. The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.
  14. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence.
  15. Subject must be considered legally capable of providing his or her own consent for participation in this study.

Exclusion Criteria:

  1. The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
  2. The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
  3. The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.
  4. The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e.

    currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.

  5. The patient has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are eligible for the study if the above exclusion criteria are not met.
  6. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
  7. The patient has a concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
  8. The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
  9. Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.
  10. The patient has dysphagia and who is unable to swallow intact capsules.
  11. The patient has active gastrointestinal disease or a disorder that alters gastrointestinal motility or absorption (i.e., lack of integrity of the gastrointestinal tract such as a significant surgical resection of the stomach or small bowel).
  12. The patient has received prior retinoid derivative therapy.
  13. The patient has triglycerides >200.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411632

Contacts
Contact: Christine Alden, BSN 713-792-0734

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Edward Kim, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Edward Kim, MD U.T. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Edward Kim, MD/Assistant Professor )
Study ID Numbers: 2005-0826
Study First Received: December 12, 2006
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00411632     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-Small Cell Lung Cancer
NSCLC
Erlotinib
Tarceva
Bexarotene
Targretin
OSI-774
Battle Program

Study placed in the following topic categories:
Anticarcinogenic Agents
Erlotinib
Thoracic Neoplasms
Respiratory Tract Diseases
Bexarotene
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Protein Kinase Inhibitors
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Anticarcinogenic Agents
Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Bexarotene
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009