Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Non-Small-Cell Lung
Intervention: Temozolomide and radiotherapy (Drug); Whole brain radiotherapy (Procedure)
Phase: Phase 2
Status: Recruiting
Sponsored by: Schering-Plough Official(s) and/or principal investigator(s):
Christine Marosi, Principal Investigator, Affiliation: General Hospital of Vienna
Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: 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.
Secondary outcome: Overall survival. The distributions for survival time will be estimated with the Kaplan-Meier method and compared using the log rank test.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 1, Vienna A-1090, Austria; Recruiting
Investigational Site 4, Graz A-8036, Austria; Completed
Investigational Site 5, Graz A-8036, Austria; Completed
Investigational Site 14, Vienna A-1145, Austria; Recruiting
Investigational Site 16, Wr. Neustadt A-2700, Austria; Completed
Investigational Site 18, Klagenfurt A-9026, Austria; Completed
Investigational Site 19, Klagenfurt A-9026, Austria; Completed
Investigational Site 20, Salzburg A-5020, Austria; Recruiting
Investigational Site 24, Feldkirch A-6807, Austria; Completed
Investigational Site 25, Linz A-4010, Austria; Recruiting
Investigational Site 26, Linz A-4020, Austria; Recruiting
Investigational Site 22, Salzburg A-5020, Austria; Recruiting
Investigational Site 2, Vienna A-1090, Austria; Recruiting
Investigational Site 11, Vienna A-1220, Austria; Completed
Investigational Site 13, Vienna A-1160, Austria; Recruiting
Investigational Site 15, St. Poelten A-3100, Austria; Completed
Investigational Site 17, Grimmenstein A-2840, Austria; Completed
Investigational Site 21, Salzburg A-5020, Austria; Recruiting
Investigational Site 3, Innsbruck A-6060, Austria; Recruiting
Investigational Site 10, Vienna A-1130, Austria; Completed
Investigational Site 6, Graz A-8020, Austria; Completed
Investigational Site 12, Vienna A-1220, Austria; Completed
Investigational Site 9, Vienna A-1130, Austria; Recruiting
Additional Information
Starting date: March 2005
Ending date: August 2009
Last updated: July 15, 2008
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