Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Condition: Colorectal Neoplasm; Head and Neck Neoplasm; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasm
MeSH terms: Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Esophageal Neoplasms
Intervention: Temozolomide
Intervention description: 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 MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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