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

Phase 2TerminatedNCT00423150

Merck Sharp & Dohme LLC86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

TemozolomideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tumor Responses (Complete and Partial Response)

Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Time frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first

Data from ClinicalTrials.gov

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