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)

NCT00266812 | Terminated Phase 2 Results

• 1 other identifier: P04071
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Keywords

temozolomide; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression-free Survival (6 Month)

  The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as \<25% increase in tumor size on CT or MRI.

  6 months

Study Arms (2)

Chemotherapy with temozolomide and radiotherapy

EXPERIMENTAL

Drug: Temozolomide and radiotherapy

Radiotherapy alone

ACTIVE COMPARATOR

Procedure: Whole brain radiotherapy

Interventions

Temozolomide and radiotherapy 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).

Also known as: Temodal, TMZ, SCH 052365

Chemotherapy with temozolomide and radiotherapy

Whole brain radiotherapy 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.

Radiotherapy alone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• AESCA Pharma GmbH: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 19, 2005
• Study Start: March 8, 2005
• Primary Completion: January 16, 2008
• Study Completion: January 16, 2008
• Last Updated: June 8, 2017
• Results First Posted: September 4, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share