A Phase 2 interventional study of erlotinib hydrochloride and sorafenib tosylate in Adult Giant Cell Glioblastoma, Adult Glioblastoma and Adult Gliosarcoma, sponsored by National Cancer Institute (NCI). Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-27.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.
PRIMARY OBJECTIVES:
I. The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme.
SECONDARY OBJECTIVES:
I. To assess and estimate the toxicities. II. Tumor response rate. III. To estimate 6-month progression free survival. IV. To describe the pharmacokinetics of this route of administration. V. For the Molecular Targeted Combinations Correlative (MTC2) Study Initiative: To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents.
OUTLINE: This is a multicenter, open-label, phase II study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue and blood samples are collected prior to beginning treatment. Samples are analyzed by immunohistochemistry, gene expression, and DNA mutation and genomic analyses of the epidermal growth factor receptor, ras-raf-ERK, and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes. Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies. Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites.
After completion of study therapy, patients are followed every 2 months.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 56 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study
Drug: erlotinib hydrochloride · Drug: sorafenib tosylate · Other: pharmacological study
150mg Given orally once daily
Also known as: OSI-774
400mg Given orally twice daily
Also known as: BAY 3-9006
Correlative studies
Overall Survival
death. measured by time of first day of treatment until date of death, assessed up to 2 years.
Time frame: Time of first day of the treatment to death, assessed up to 2 years
6months -Progression-free Survival Rate
defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
Time frame: At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
Adult pts accured in an outpatient clinic between Jan 2007 and October 2007. pts had to have measurable , histologically proven GBM, that had progressed following radiation therapy and 0-2 prior chemotherapies.
| Milestone | Treatment |
|---|---|
| Started | 56 |
| Completed | 56 |
| Not completed | 0 |
death. measured by time of first day of treatment until date of death, assessed up to 2 years.
| months | Treatment |
|---|---|
| Overall Survival | 5.7 (4.5 to 7.9) |
defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
| percentage of participants | Treatment |
|---|---|
| 6months -Progression-free Survival Rate | 14 (8 to 28) |
Collected over events collected from first day of dosing till off treatment - approximately 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 0/56 (0%) | 9/56 (16.1%) |
| Event | Treatment |
|---|---|
| fatigueGeneral disorders | 5/56 |
| lipase increasedInvestigations | 4/56 |
histologically confirmed GBM, progressed or recurred following RT and 0-2 prior chemotherapy regimens
| Age, Continuous(years) | Treatment |
|---|---|
| Median | 56 (31 to 78) |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 21 |
| Male | 35 |
| Karnosky Performance Status(participants) | Treatment |
|---|---|
| 90-100 | 26 |
| 60-80 | 30 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute (NCI)