QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

NCT00385398 | Withdrawn Phase 2 DMC

• 5 other identifiers: 030601P30CA0727200220060108CINJ-NJ1506CDR0000539474
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment. PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

tumors metastatic to brain; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  2 years

Secondary Outcomes (6)

• Tumor response

  2 years

• Time to tumor progression in brain

  2 years

• Survival

  2 years

• Quality of life as measured by FACT subscale

  2 years

• Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living

  2 years

Interventions

erlotinib hydrochloride DRUG

Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.

temozolomide DRUG

Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.

stereotactic radiosurgery RADIATION

Stereotactic radiosurgery will be performed prior to chemotherapy.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer meeting the following criteria: * One to 3 brain metastases, meeting the following criteria: * No larger than 3 cm * Greater than 5 mm from the optic apparatus * Not involving the brainstem, pons, medulla, or midbrain * Stable systemic disease for the past 3 months * Less than 3 months since completion of primary treatment * Measurable CNS disease as defined by RECIST criteria * No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation PATIENT CHARACTERISTICS: * Life expectancy ≥ 12 weeks * Karnofsky performance status 60-100% * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 3.0 times ULN * Serum creatinine ≤ 1.5 mg/dL * Creatinine clearance \> 50 mL/min * No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation * No concurrent active infections * No known HIV positivity * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior complete resection of all brain metastases * No prior brain radiation therapy * No prior temozolomide or erlotinib hydrochloride * No concurrent enzyme-inducing anti-epileptic drugs * No concurrent recombinant interleukin-11 * No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery * No concurrent enrollment on another clinical trial * Surgery for symptomatic brain lesions prior to radiosurgery allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Schering-Plough: collaborator
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Temozolomide; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Molly Gabel, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

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: October 5, 2006
• First Posted: October 9, 2006
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 2, 2013

Record last verified: 2013-08