Clinical trial · Interventional

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

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

NCT00423150CI-TRIAL-00028044terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Non-Small-Cell Lung	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Colorectal Neoplasm	Colorectal Neoplasm	ONTOLOGY_EXACT	0.98
Esophageal Neoplasm	Esophageal Neoplasm	ONTOLOGY_EXACT	0.98
Head and Neck Neoplasm	Head and Neck Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Temozolomide	Drug	Temozolomide	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Temozolomide
interventionNames
1. Drug: Temozolomide

Primary outcomes (1)

measure
Tumor Responses (Complete and Partial Response)
timeFrame
From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTHochhauser 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