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)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Schering-Plough Quintiles
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00831545

Purpose

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.

Condition	Intervention	Phase
Metastases of Central Nervous System Melanoma Breast Neoplasm Carcinoma, Non-Small-Cell Lung	Drug: Temozolomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-Small Cell Lung Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Melanoma

Drug Information available for: Temozolomide

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Best response related to brain metastases observed during the study period. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival, brain progression-free survival, and overall survival. [ Time Frame: 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. ] [ Designated as safety issue: No ]
Adverse events according to NCI CTC grading system of toxicity. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]

Enrollment:	162
Study Start Date:	December 2000
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Subjects with melanoma: Experimental	Drug: 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).
Subjects with breast cancer: Experimental	Drug: 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).
Subjects with non-small cell lung cancer: Experimental	Drug: 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).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02064
Study First Received:	January 15, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831545 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Thoracic Neoplasms
Skin Diseases
Breast Neoplasms
Temozolomide
Melanoma
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neoplasm Metastasis
Neuroepithelioma
Non-small Cell Lung Cancer
Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Melanoma
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Nevi and Melanomas
Alkylating Agents

Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Temozolomide
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Antineoplastic Agents, Alkylating
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009