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

NCT00423150 | Terminated Phase 2 Results

• 1 other identifier: P04273
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Temozolomide

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

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.

Also known as: Temodal, TMZ, SCH 52365

Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23443801 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to low response rate for colorectal cancer in interim analyses, low enrollment in head \& neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: January 18, 2007
• Study Start: January 26, 2007
• Primary Completion: June 11, 2009
• Study Completion: June 11, 2009
• Last Updated: June 8, 2017
• Results First Posted: July 5, 2010

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share