Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer

NCT00408499 | Completed Phase 1 Results DMC

• 5 other identifiers: CDR0000517090P30CA093373UCDCC-177BMS-4608BMS-CA225-261
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib together with cetuximab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Number of Patients Experiencing a DLT

  Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity

  baseline through cycle 1 of treatment

• Number of Patients Correlated With Best Overall Response.

  To determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.

  Every two cycles from first dose to last dose of study drugs

Secondary Outcomes (1)

• Patient Outcome

  Patients will be followed until death

Study Arms (1)

Erlotinib + Cetuximab

EXPERIMENTAL

Daily erlotinib combined with weekly cetuximab

Drug: cetuximab; Drug: erlotinib

Interventions

cetuximab DRUG

Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.

Also known as: Erbitux

Erlotinib + Cetuximab

erlotinib DRUG

Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.

Also known as: Tarceva

Erlotinib + Cetuximab

Eligibility Criteria

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

You may qualify if:

• For the phase I portion of the study (completed 10/05/08), patients must have cytologically or histologically proven advanced solid tumors for which there is no standard effective therapy available.
• Any number of prior chemotherapy regimens are allowed for the both the Phase I and Phase II portions
• For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC. Patients with NSCLC that have progressed or recurred after first-line therapy for stage IIIA or IIIB may also be considered.
• Patients must have measurable disease by RECIST criteria for the Phase II portion. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. Patients with evaluable disease (bone metastases, pleural fluid, ascites, etc.) may be included in the phase I portion of the trial (completed 10/08/08).
• Must be 18 years of age or older.
• Patients must have a performance status of 0 -2.
• Patients must have an estimated survival of at least 3 months.
• Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. For prior mitomycin chemotherapy a 6-week interval is required. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible medically significant side effects of prior chemotherapy regimens or radiotherapy to NCI-CTC \< grade 1 (excluding alopecia). Prior herceptin is allowed.
• Patients must have adequate renal function as documented by a serum creatinine \< 1.5 mg/dl or a calculated creatinine clearance of \> 45 ml/min (see protocol Appendix D for formula for calculating creatinine clearance).
• Patients must have adequate liver function as documented by serum bilirubin \< 1.5 x ULN. AST must be \< 2.5 x institutional upper limit of normal.
• Patients must have a pretreatment granulocyte count of \>1500/mm3 and platelet count of \>100 000/mm3.
• Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 2 weeks.
• All patients must give voluntary written informed consent.
• Patients must be able to take and retain oral medication.
• Documentation of a negative serum pregnancy test.

You may not qualify if:

• Patients who have received erlotinib, cetuximab, or any other EGFR-directed therapy (excluding herceptin).
• Patients with symptomatic brain metastasis or still requiring steroids and anti-convulsants may not be included.
• For the phase II portion of the study, no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, and any other cancer from which the patient has been disease-free for over five years
• Patients with acute hepatitis or known HIV.
• Patients with active or uncontrolled infection.
• Patients with significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• Patients with prior severe infusion reaction to a monoclonal antibody.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
• Pregnant or breastfeeding females as the effects of these drugs on the unborn fetus are unknown.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Data Manager
• Organization: University of California, Davis

nmahaffey@ucdavis.edu

916-734-8381

Study Officials

• David R. Gandara, MD

  University of California, Davis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: January 1, 2013
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-01

Locations

US (1)