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

Not Applicable

• Conditions: -C189 Colon, unspecified-C349 Bronchus or lung, unspecified-C760 Head, face and neck-C159 Oesophagus, unspecified; Oesophagus, unspecified; Colon, unspecified; Bronchus or lung, unspecified; Head, face and neck; C159; C189; C349; C760

• Registration Number: PER-023-07
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must be 18 years of age and can be of any sex and race.
2. Subjects must have one of the following types of confirmed tumors: a. CRC: metastatic disease. b. NSCLC: locally advanced, inoperable or metastatic disease. c. Head and neck cancer: metastatic disease. d. Esophageal cancer: metastatic disease.
3. The subjects must have a tumor sample obtained to establish an initial diagnosis and a serum or plasma sample taken during the selection period.
4. Subjects should show methylation of the MGMT promoter in the most recent sample of tumor tissue or in the serum or plasma sample.
5. The disease must be recurrent or recurrent and there must be no alternative treatment available that can offer a cure.
6. Subjects must meet the requirements listed below: a. CRC: up to 3 previous schemes. b. NSCLC: up to 2 previous schemes. c. Head and neck cancer: up to 1 previous schedule. d. Esophageal cancer: up to 1 previous scheme.
7. All clinically significant toxic effects of any surgery, radiotherapy, biological therapy, immunotherapy, targeted therapy or chemotherapy prior to Grade <1 should have been resolved.
8. Subjects must have at least one measurable lesion.
9. The subjects must have a performance of 0, 1 or 2 according to the Eastern Cooperative Oncology Group (ECOG).
10. The subjects must have an adequate hematological, renal and hepatic function.
11. The subjects must have the will to give their informed consent in writing and be able to comply with the dosage schedule and visits.
12. Subjects must have a life expectancy greater than 12 weeks.
13. Subjects should be able to take the capsules of the study medication orally.
14. Fertile women, as well as men and their fertile female partners, who have an active sex life should agree to use an acceptable method of contraception.
15. Fertile women, as well as men and their fertile female partners, who do not lead an active sex life must agree to use an acceptable method of contraception while receiving the medication specified by the protocol and during the 6 months after stopping treatment in case of starting their sexual life during participation in the study.

Exclusion Criteria

1. Subjects who have had another type of cancer within 5 years prior to the start of the study.
2. Subjects with known cerebral or subarachnoid metastases.
3. Subjects with cardiovascular, hepatic, neurological, endocrine, or other clinically significant systemic disease that may hinder the performance of the protocol.
4. Subjects who have previously received treatment with temozolomide or dacarbazine.
5. Women who are breastfeeding, pregnant or who intend to become pregnant.
6. Subjects with any disease or clinically significant condition, in addition to the disease under study, that may affect the study´s evaluations or prevent optimal participation in the study.
7. Subjects who have used a drug in research within 30 days prior to the start of treatment under study.
8. Subjects who are participating in some other clinical study.
9. Subjects that are part of the personnel directly related to the study.
10. Subjects that are family members of the research study staff.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The response index is obtained from the sum of the Complete Response or objective tumor response and the Partial Response, defined according to the RECIST criteria. The complete response defines the disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor markers. The partial response is defined as the decrease of at least 30% in the sum of the largest diameters of the target lesions. To obtain these data, CT and MRI images will be used, according to clinical criteria.<br>Measure:Response rate.<br>Timepoints:At the end of the study: When unacceptable toxicity occurs, the disease progresses or consent is withdrawn.<br>