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

Primary Purpose

Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Temozolomide

    Arm Description

    Outcomes

    Primary Outcome Measures

    Tumor Responses (Complete and Partial Response)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2006
    Last Updated
    May 12, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00423150
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 26, 2007 (Actual)
    Primary Completion Date
    June 11, 2009 (Actual)
    Study Completion Date
    June 11, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Temozolomide
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Other Intervention Name(s)
    Temodal, TMZ, SCH 52365
    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.
    Primary Outcome Measure Information:
    Title
    Tumor Responses (Complete and Partial Response)
    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.
    Time Frame
    From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    23443801
    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.
    Results Reference
    result

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

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