Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)

NCT ID: NCT00831545

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-01
• Study Completion Date: 2006-10-20

Brief Summary

The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If >=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if >=10 patients will respond. If <2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.

Conditions

Metastases of Central Nervous System; Melanoma; Breast Neoplasm; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with melanoma

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).

Subjects with breast cancer

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).

Subjects with non-small cell lung cancer

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).

Interventions

Temozolomide

150 mg/m2 given once a day for 7 consecutive days (Days 1 through 7) repeated every other week until disease progression or toxicity or for a maximum of one year. After amendment, schedule was modified: a second rest week was added after the second wash-out week (Days 1 through 7, 15 through 21 every 35).

Intervention Type: DRUG

Other Intervention Names

SCH 52365

Eligibility Criteria

Inclusion Criteria

• Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
• Brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
• Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
• Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
• Age <=70 years.
• Performance status 0-2 (ECOG-WHO scale).
• Blood leukocytes >=3.5 x 10^9/L and platelets >=100 x 10^9/L.
• Bilirubin <=25 M/L.
• Seric transaminases <=2 x upper limit of normal values.
• Creatinine <=150 M/L, creatinine clearance >=60 mL/min.
• Signed written informed consent.

Exclusion Criteria

• Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
• Previous whole brain irradiation.
• Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
• Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
• Pregnant or nursing women.
• Acute infection requiring intravenous antibiotics.
• Severe vomiting or medical condition which could interfere with oral medication intake.
• Anticonvulsant chronic therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Siena S, Crino L, Danova M, Del Prete S, Cascinu S, Salvagni S, Schiavetto I, Vitali M, Bajetta E. Dose-dense temozolomide regimen for the treatment of brain metastases from melanoma, breast cancer, or lung cancer not amenable to surgery or radiosurgery: a multicenter phase II study. Ann Oncol. 2010 Mar;21(3):655-661. doi: 10.1093/annonc/mdp343. Epub 2009 Sep 18.

Reference Type: RESULT

PMID: 19767314 (View on PubMed)

Study Documents

Document Type: CSR Synopsis Links

View Document

Other Identifiers

P02064

Identifier Type: -

Identifier Source: org_study_id