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. - P04273

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

1. Subjects must have one of the following histologically or cytologically confirmed tumor types: a. CRC: metastatic disease. b. NSCLC: locally advanced, inoperable, or metastatic disease. Eligible histologies include (but are not restricted to) squamous cell, adenocarcinoma, adenosquamous carcinoma, and large cell carcinoma. c. H & N cancer: metastaatic disease, including squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx. d. Esophageal cancer: metastatic disease, including (but not restricted to) squamous cell carcinoma and adenocarcinoma, and also including cancers at the gastroesophageal junction. 2. Subjects must have a tumor sample available from initial diagnosis or later and a serum/plasma sample taken during the screening period. The available tumor samples can be from the biopsy or surgical resection of primary or metastatic lesions. 3. Subjects must demonstrate methylated MGMT promoter in the most recent tumor tissue sample or in the serum/plasma sample. 4. Subjects must have relapsed or recuurent disease with no other potentially curative treatment option available in the opinion of the investigator. 5. Subjects must meet the requirements listed below regarding their prior chemotherapy, biological therapy, immunotherapy, or targeted therapy for metastatic disease. In addition to the prior therapy limits below, subjects may also have received adjuvant ot neoadjuvant therapy. a. CRC: no more than 3 prior regimens. b. NSCLC: no more than 2 prior regimens. c. H & N cancer: no more than 1 prior regimen. d. Esophageal cancer: no more than 1 prior regimen. 6. Subjects must have resolution of all clinically significant toxic effects (excluding alopecia, acne, skin rash) of any prior surgery, radiotherapy, biological therapy, immunotherapy, targeted therapy or chemotherapy to Grade /= 1,500/mm3 b. Platelet coount >/= 100,000/mm3 c. Hemoglobin >/= 9 g/dl d. Blood urea nitrogen(BUN)/urea and serum creatinine Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have had any other type of cancer within 5 years of study start, with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma of the skin. 2. Subjects with known (past or present) brain or leptomeningeal metastasis. 3. Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease that would make implementation of the protocol difficult. 4. Subjects who received prior temozolomide or dicarbazine treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine response rate (complete and partial response) for temozolomide when administered orally on Days 1 to 7 and Days 15-21 of each 28 day cycle in subjects with methylated MGMT promoter.;Secondary Objective: To evaluate the safety of temozolomide and estimate response duration, time to disease progression, and overall survival.;Primary end point(s): Response rate (complete and partial).

Secondary Outcome Measures

Name	Time	Method

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