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)
This study has been terminated.
(Patient target could not be reached within the planned timeframe.)
Sponsor:
Schering-Plough
Collaborator:
AESCA Pharma GmbH
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00266812
First received: December 16, 2005
Last updated: July 29, 2009
Last verified: July 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Number of Participants With Progression-free Survival (6 Month) [ 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 |
|---|---|
| Experimental: Chemotherapy with temozolomide and radiotherapy |
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).
Other Name: Temodal, TMZ, SCH 052365
|
| Active Comparator: Radiotherapy alone |
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 unidimensionally 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 >=70%.
- 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
No publications provided
| Responsible Party: | Gerhard Wildauer, MD - Medical Director, Austria Country Operations, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00266812 History of Changes |
| Other Study ID Numbers: | P04071 |
| Study First Received: | December 16, 2005 |
| Results First Received: | July 29, 2009 |
| Last Updated: | July 29, 2009 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by Schering-Plough:
|
temozolomide radiotherapy |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013