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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasm

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Responses (Complete and Partial Response)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P04273

NCT ID:

NCT00423150

Start Date:

January 2007

Completion Date:

June 2009

Related Keywords:

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

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