Clinical trial NCT00423150: Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Official title: A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasm
Head and Neck Neoplasm
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor Responses (Complete and Partial Response)
timeFrame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.