Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

NCT ID: NCT00423150

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-26
• Study Completion Date: 2009-06-11

Brief Summary

This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.

Conditions

Colorectal Neoplasm; Head and Neck Neoplasm; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.

Interventions

Temozolomide

Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.

Intervention Type: DRUG

Other Intervention Names

Temodal, TMZ, SCH 52365

Eligibility Criteria

Inclusion Criteria

• Participants must be at least 18 years of age.
• Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
• Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
• Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer.
• Participants must have at least one measurable lesion.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have adequate hematologic, renal, and liver functions.
• Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
• Participants of childbearing potential must agree to use a medically accepted method of contraception.

Exclusion Criteria

• Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
• Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
• Participants who received prior temozolomide or dacarbazine treatment

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Hochhauser D, Glynne-Jones R, Potter V, Gravalos C, Doyle TJ, Pathiraja K, Zhang Q, Zhang L, Sausville EA. A phase II study of temozolomide in patients with advanced aerodigestive tract and colorectal cancers and methylation of the O6-methylguanine-DNA methyltransferase promoter. Mol Cancer Ther. 2013 May;12(5):809-18. doi: 10.1158/1535-7163.MCT-12-0710. Epub 2013 Feb 26.

Reference Type: RESULT

PMID: 23443801 (View on PubMed)

Other Identifiers

P04273

Identifier Type: -

Identifier Source: org_study_id