Status:
TERMINATED
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Colorectal Neoplasm
Head and Neck Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-sm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00423150
Start Date
January 26 2007
End Date
June 11 2009
Last Update
June 8 2017
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