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)
This study has been completed.
Sponsor:
Schering-Plough
Collaborator:
Quintiles
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00831545
First received: January 15, 2009
Last updated: January 28, 2009
Last verified: January 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
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 |
|---|---|
| Experimental: Subjects with melanoma |
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).
Other Name: SCH 52365
|
| Experimental: Subjects with breast cancer |
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).
Other Name: SCH 52365
|
| Experimental: Subjects with non-small cell lung cancer |
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).
Other Name: SCH 52365
|
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: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00831545 History of Changes |
| Other Study ID Numbers: | P02064 |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 28, 2009 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Melanoma Neoplasm Metastasis Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 18, 2012
