A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Median Survival
Study Overview
Brief Summary
The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).
Detailed Description
The Study Drugs:
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take the study drug on Days 1-6 before receiving radiation therapy. You will take 1 pill each day at least 1 hour before or 2 hours after eating. You will take the study drug while you are receiving radiation therapy. You will continue to take the study drug daily after the radiation therapy is complete for as long as the study doctor thinks it is necessary.
You will record at what time each day you take the study drug on a calendar that the will be provided to you. You will bring this calendar with you to each of your study visits.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological confirmation of non-small cell lung cancer
- •Patients who have been treated in the past with stereotactic radiosurgery, stereotactic radiotherapy, GliaSite or surgical resection will be allowed to enroll in this study
- •A diagnostic contrast-enhanced MRI or CT scan must be performed, demonstrating brain metastases
- •Patients must have KPS >/= 70
- •Patients cannot be treated on any other treatment related protocols within 30 days prior to study entry or during participation in the study
- •No uncontrolled or symptomatic major medical illnesses or psychiatric impairments, such as Alzheimer's or schizophrenia
- •Screening Clinical Laboratory Values: ANC >1500/ul, Platelets >80,000/ul, baseline AST and/or ALT within normal limits (within 30 days of starting protocol treatment)
- •All women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (abstinence, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
- •Continued from #10: All women of child-bearing potential must have a negative serum pregnancy test and practice birth control while on study.
- •Patients must provide verbal and written informed consent to participate in the study.
Exclusion Criteria
- •Prior cranial radiation therapy, other than stereotactic radiosurgery, Stereotactic Radiotherapy or GliaSite.
- •Patients with known Acquired Immune Deficiency (AIDS), as regimens with tyrosine kinase inhibitors may pose a safety risk related to excess toxicity or interference with anti-viral effectiveness
- •Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant due to study drug
- •Patients with active connective tissue disorders, such as lupus or scleroderma
Arms & Interventions
Tarceva + RT
Tarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Intervention: Tarceva (Erlotinib hydrochloride) (Drug)
Tarceva + RT
Tarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Intervention: Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Median Survival
Time Frame: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 2 years.
Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.
Secondary Outcomes
- Number of Participants With Overall Survival(From date of registration until the date of first documented death or lost to follow up, whichever came first, assessed up to 2 years.)