Gemcitabine Hydrochloride and Carboplatin With or Without MK-0646 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without MK-0646 as First-Line Therapy in Advanced Squamous Non-Small Cell Lung Carcinoma

Status Withdrawn

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as MK-0646, 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. It is not yet known whether gemcitabine hydrochloride and carboplatin are more effective when given together with or without MK-0646 in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying how well gemcitabine hydrochloride and carboplatin work when given together with or without MK-0646 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• To assess and compare the progression-free survival of patients with stage IIIB or IV squamous cell non-small cell lung cancer treated with gemcitabine hydrochloride and carboplatin with vs without MK-0646 as first-line therapy.

Secondary

• To assess and compare the objective tumor response rate in patients treated with these regimens.

• To assess and compare the duration of response in patients with objective tumor response treated with these regimens.

• To assess and compare the time to progression and time to treatment failure in patients treated with these regimens.

• To assess and compare the 1-year overall survival of patients treated with these regimens.

• To assess and compare the clinical toxicities of these regimens in these patients.

• To compare the quality of life of patients treated with these regimens.

Tertiary

• To collect blood and tumor specimens for future evaluation of pharmacogenetic and proteomic markers of tumor response and toxicity to therapy.

• To assess the relationship between ht-SNPs in genes that mediate chemosensitivity/resistance to gemcitabine hydrochloride (e.g. ribonucleotide reductase) and IGF1R pathway genes.

• To bank paraffin-embedded tissue blocks/slides for future histochemistry evaluation and DNA extraction as part of ongoing research for NCCTG lung studies.

OUTLINE: This is a multicenter study. Patients are stratified according to prior adjuvant therapy, neoadjuvant therapy, or chemoradiotherapy (yes vs no), and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and MK-0646 IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with stable disease or partial or complete response may then receive MK-0646 alone on days 1 and 15. Treatment with MK-0646 repeats every 28 days in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive gemcitabine hydrochloride and carboplatin as in arm I. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may crossover to arm I upon disease progression.

Blood and tissue samples may be collected for pharmacogenetics and further laboratory analysis.

Quality of life is assessed at baseline and periodically during study.

After completion of study treatment, patients are followed up periodically for up to 5 years. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00951444
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Withdrawn
• Phase: Phase 2