Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED) - Full Text View

Sponsors and Collaborators:	Schering-Plough AESCA Pharma GmbH
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00266812

Purpose

This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and MRI performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Temozolomide and radiotherapy Procedure: Whole brain radiotherapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced NSCLC Patients With CNS Metastasis Versus Radiotherapy Alone

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Progression free survival which will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by clinical follow-up, brain MRI, and thoracic CT scans. Quality of life will also be evaluated. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival. The distributions for survival time will be estimated with the Kaplan-Meier method and compared using the log rank test. [ Time Frame: Time from randomization to death ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	March 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Chemotherapy with temozolomide and radiotherapy: Experimental	Drug: Temozolomide and radiotherapy Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
Radiotherapy alone: Active Comparator	Procedure: Whole brain radiotherapy 2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior histologic confirmation of non-small cell lung cancer (NSCLC).
Optional: NSCLC histologic confirmation of metastasis of NSCLC.
Presence of bidimensionally measurable disease in the brain.
No 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.
Age: >18 years.
Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
Karnofsky Performance status >=60%.
Absolute neutrophil count (ANC) >1,500/mm**3, platelets >100,000/mm**3, hemoglobin >8 g/dL.
Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <3 times upper limit of testing laboratory.
Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
Written informed consent.

Exclusion Criteria:

Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
Surgery within two weeks prior to temozolomide administration.
RPA class III
Patients with a single brain metastasis amenable to radiosurgery of resection
Known HIV disease.
Acute infection requiring intravenous antibiotics.
Any reason making compliance to the protocol improbable.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Gerhard Wildauer, MD - Medical Director, Austria Country Operations )
Study ID Numbers:	P04071
Study First Received:	December 16, 2005
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00266812
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Schering-Plough:

temozolomide
radiotherapy

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Neoplasm Metastasis
Temozolomide
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009