Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)

NCT ID: NCT00266812

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-08
• Study Completion Date: 2008-01-16

Brief Summary

This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy with temozolomide and radiotherapy

Group Type: EXPERIMENTAL

Temozolomide and radiotherapy

Intervention Type: DRUG

Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).

Radiotherapy alone

Group Type: ACTIVE_COMPARATOR

Whole brain radiotherapy

Intervention Type: PROCEDURE

2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Interventions

Temozolomide and radiotherapy

Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).

Intervention Type: DRUG

Whole brain radiotherapy

2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Intervention Type: PROCEDURE

Other Intervention Names

Temodal, TMZ, SCH 052365

Eligibility Criteria

Inclusion Criteria

• Prior histologic confirmation of non-small cell lung cancer (NSCLC).
• Optional: NSCLC histologic confirmation of metastasis of NSCLC.
• Presence of unidimensionally measurable disease in the brain.
• No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
• Age: >18 years.
• Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
• Karnofsky Performance status >=70%.
• Absolute neutrophil count (ANC) >1,500/mm^3, platelets >100,000/mm^3, hemoglobin >8 g/dL.
• Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <3 times upper limit of testing laboratory.
• Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
• Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
• Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
• Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
• Written informed consent.

Exclusion Criteria

• Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
• Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
• Surgery within two weeks prior to temozolomide administration.
• Recursive Partitioning Analysis (RPA) class III
• Patients with a single brain metastasis amenable to radiosurgery of resection
• Known Human Immunodeficiency Virus (HIV) disease.
• Acute infection requiring intravenous antibiotics.
• Any reason making compliance to the protocol improbable.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AESCA Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04071

Identifier Type: -

Identifier Source: org_study_id