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)

NCT00831545 | Completed Phase 2

• 1 other identifier: P02064
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Best response related to brain metastases observed during the study period.

  After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.

Secondary Outcomes (2)

• Progression-free survival, brain progression-free survival, and overall survival.

  After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.

• Adverse events according to NCI CTC grading system of toxicity.

  Throughout the study.

Study Arms (3)

Subjects with melanoma

EXPERIMENTAL

Drug: Temozolomide

Subjects with breast cancer

EXPERIMENTAL

Drug: Temozolomide

Subjects with non-small cell lung cancer

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide 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).

Also known as: SCH 52365

Subjects with breast cancer; Subjects with melanoma; Subjects with non-small cell lung cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Quintiles, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 19767314 RESULT

MeSH Terms

Conditions

Melanoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 29, 2009
• Study Start: December 1, 2000
• Primary Completion: October 20, 2006
• Study Completion: October 20, 2006
• Last Updated: May 9, 2017

Record last verified: 2017-05