TriangleNCT00423150 · REGISTRY CONDITION SEARCH
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2017-06-08
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Temozolomide
- label
- Temozolomide
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Temozolomide
- 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.
- name
- Temozolomide
- other Names
- Temodal, TMZ, SCH 52365
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 86
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- 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
Full 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.
Source references
- references
- 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.
- pmid
- 23443801
- type
- RESULT
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- NCT00423150
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- payload
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- exact text
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- offset unit
- unicode_code_points
- query cond
- Small Intestine Cancer
- query disease state id
- ds-small-intestine-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
- source file sha256
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- source json pointer
- /studies/121/protocolSection/identificationModule/nctId
- source kind
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- Source null
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- source string sha256
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Preserved source evidence · Not medical advice