Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

NCT00445588 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2012-03018CDR531731NABTT 0502NABTT-0502U01CA062475
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  death. measured by time of first day of treatment until date of death, assessed up to 2 years.

  Time of first day of the treatment to death, assessed up to 2 years

Secondary Outcomes (1)

• 6months -Progression-free Survival Rate

  At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

erlotinib hydrochloride DRUG

150mg Given orally once daily

Also known as: OSI-774

Treatment

sorafenib tosylate DRUG

400mg Given orally twice daily

Also known as: BAY 3-9006

Treatment

pharmacological study OTHER

Correlative studies

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed supratentorial glioblastoma multiforme which is progressive or recurrent after radiation therapy ± chemotherapy; patients with previous low grade glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to have a high grade glioma are eligible
• Patients must have tissue specimens available and agree to have their blood and tissue blocks (or slides) submitted for the combined correlative studies
• Patients must have measurable contrast enhancing progressive or recurrent glioblastoma multiforme by MRI or CT imaging (Within 14 days before starting treatment)
• Patients must have recovered from toxicity of prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation therapy, while at least 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen, and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen; NOTE: For a non-cytotoxic, FDA approved agents (i.e. Celebrex, thalidomide, etc.) therapy could be started 2 weeks after discontinuing this agent provided the patient has fully recovered from all toxicity associated with the agent; for investigational, non-cytotoxic agents a minimum of 3 weeks must have elapsed before the patient will be eligible for this study
• Patients must have a Karnofsky performance status \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
• Absolute Neutrophil Count \>= 1500/mm\^3
• Platelets \>= 100,000/mm\^3
• Creatinine =\< 1.7mg/dl
• Total Bilirubin within normal institutional limits
• Transaminases =\< 2.5 times above the upper limits of the institutional norm
• PT, PTT ≤ institutional norm
• Patients must be able to provide written informed consent
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative serum pregnancy test; (the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant)
• Patients must have a Mini Mental State Exam score \>= 15

You may not qualify if:

• Patients with serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety; (examples of medical illnesses are \[but not limited to\] the following: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements)
• Patients with uncontrolled hypertension; hypertension with systolic blood pressure of \> 140 mmHg or diastolic pressure \> 90 mmHg; however, patients with well-controlled hypertension are eligible
• Patients who are pregnant or breast-feeding (the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant)
• Patients who have received more than two prior treatments
• Patients who have had prior therapy with erlotinib or sorafenib or any other agent targeting EGFR
• Patients receiving concurrent therapy for their tumor (with the exception of steroids)
• Patients undergoing major surgery or sustaining a significant traumatic injury within 21 days prior to treatment are ineligible
• Patients with a concurrent malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients with a prior malignancy are ineligible unless they have been free of disease for \>= five years
• Patients must not have any evidence of bleeding diathesis or coagulopathy
• Patients with PT INR \> 1.5 are excluded, unless the patient is on full dose warfarin
• Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met:
• The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
• The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• NOTE: Patients on a full dose of anticoagulants will a different schedule for PT/INR evaluations
• Prophylactic anticoagulation (i.e. low dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (INR; International Normalized Ratio of prothrombin time) \< 1.1 x institutional upper limit of normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Peereboom DM, Ahluwalia MS, Ye X, Supko JG, Hilderbrand SL, Phuphanich S, Nabors LB, Rosenfeld MR, Mikkelsen T, Grossman SA; New Approaches to Brain Tumor Therapy Consortium. NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme. Neuro Oncol. 2013 Apr;15(4):490-6. doi: 10.1093/neuonc/nos322. Epub 2013 Jan 17.

  PMID: 23328813 RESULT

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

Erlotinib Hydrochloride; Sorafenib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: David Peereboom, MD
• Organization: Adult Brain Tumor Consortium

peerebd@ccf.org

216-445-6068

Study Officials

• David Peereboom, MD

  New Approaches to Brain Tumor Therapy Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 27, 2016
• Results First Posted: April 27, 2016

Record last verified: 2016-03

Locations

US (9)