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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00423150

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:

MedlinePlus related topics: Cancer Colorectal Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
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:	September 23, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012