S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer

NCT00087412 | Completed Phase 2

• 4 other identifiers: NCI-2012-03060S0341U10CA032102CDR0000377245
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Conditions

Adenocarcinoma of the Lung; Large Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Median survival

  Up to 3 years

Secondary Outcomes (2)

• Response rates (confirmed plus unconfirmed, complete plus partial)

  Up to 3 years

• Toxicity rates graded according to the NCI CTCAE version 3.0

  Up to 3 years

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment

laboratory biomarker analysis 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 or cytologically proven newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurrent disease after previous surgery and/or irradiation
• Patients with brain metastases are ineligible; all patients with neurological abnormalities on physical exam or symptoms must have a negative pretreatment CT or MRI scan of the brain within 28 days prior to registration
• Patients must have measurable disease documented by CT, MRI, X-ray, physical exam or nuclear exam within 28 days prior to registration; non-measurable disease must be assessed within 42 days prior to registration
• Patients must have a Zubrod performance status of 2
• Patients may have received prior radiation therapy provided that at least three weeks have elapsed since the completion of prior radiation therapy and patients have recovered from all associated toxicities; measurable disease must be present outside the previous radiation field or a new lesion must be present
• Patients may have received prior surgery provided that at least three weeks have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities; patients must have measurable residual disease present outside the area of surgical resection
• Patients must not have received prior hormonal, systemic (chemotherapy) or biologic therapy for non-small cell lung cancer; patients must not have received prior therapy with EGFR inhibitors
• Patients must not be currently receiving or planning to receive concurrent hormonal, biologic or radiation therapy to measurable or non-measurable lesions except patients may receive concurrent palliative radiation therapy to small field non-measurable sites of disease (painful bony metastases) as long as there are other sites of measurable disease outside of the radiation treatment field
• ANC of \>= 1,500/ul
• Platelet count of \>= 100,000/ul
• Serum bilirubin =\< the institutional upper limit of normal (IULN) AND must satisfy one of the following:
• Alkaline phosphatase =\< IULN and liver enzymes (SGOT or SGPT) =\< 2 x the IULN
• Alkaline phosphatase =\< 4 x the IULN and liver enzymes (SGOT or SGPT) =\< the IULN
• Serum creatinine =\< 2 mg/dl
• Patients must not have gastrointestinal tract disease resulting in an inability to take enteral medication, malabsorption syndrome, a requirement for IV alimentation, had prior surgical procedures affecting absorption or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul Hesketh

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

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: July 8, 2004
• First Posted: July 12, 2004
• Study Start: September 1, 2004
• Primary Completion: July 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)