A Phase 2 interventional study of erlotinib hydrochloride and temozolomide in CNS Tumor, Adult, sponsored by David Peereboom. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-06.
Sponsored by David Peereboom · Phase 2, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma multiforme.
OBJECTIVES:
OUTLINE: This is a non-randomized study.
Patients receive oral temozolomide once daily on days 1-42 and undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Four weeks after completion of radiotherapy and temozolomide, patients receive oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.
This study's enrollment of 27 is below the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →David Peereboom is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically proven glioblastoma multiforme
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Drug: erlotinib hydrochloride · Drug: temozolomide · Radiation: radiation therapy
Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.
Also known as: Tarceva
TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.
Also known as: Temodar
Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.
Also known as: RT
Progression-free survival
Time frame: at 6 months
Progression Free Survival
Time frame: at 1 yr
Number of patients that experience toxicity (CTCAE V2)
Time frame: at 6 months
Overall Survival
Time frame: date of final follow up visit
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Erlotinib · Temozolomide
Central Nervous System Neoplasms →