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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00423150
First received: November 30, 2006
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasm
Head and Neck Neoplasm
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasm
Drug: Temozolomide
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Tumor Responses (Complete and Partial Response) [ Time Frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first ] [ Designated as safety issue: No ]

    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.



Enrollment: 86
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temozolomide Drug: Temozolomide
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.
Other Name: Temodal, TMZ, SCH 52365

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00423150     History of Changes
Other Study ID Numbers: P04273
Study First Received: November 30, 2006
Results First Received: May 27, 2010
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014