NCT00799240

MK-0646 Insulin Growth Factor 1 Receptor Antibody in Stage IIIb or IV Metastatic Non-Squamous Lung Cancer

MK-0646 IMPACT Study: MK-0646, Insulin Growth Factor 1 Receptor Antibody in Stage IIIB or IV Metastatic Non-Squamous Lung Cancer, Combined With Pemetrexed (Alimta) and Cisplatin, a Randomized Phase II Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the rate of chemotherapy: pemetrexed and cisplatin compared with the combination of pemetrexed/cisplatin with MK-0646. The other purposes are to determine how long we can control the cancer growth and toxicity and safety of the combination. Laboratory research with the tumor tissue and blood obtained will be done to assess IGF-1R expression and related markers and correlate with response and survival.

Detailed description

Insulin-like Growth factor 1 receptor (IGF-1R) is a tyrosine kinase receptor that regulates cell growth, proliferation and apoptosis.(4) Increased IGF1 signaling results in upregulation of proliferation and inhibition of apoptosis through RAF and PI3K pathways.(5) Several types of cancer, including non-small cell lung cancer, express IGF-1R and its ligand. The sequestration of IGF by IGF binding protein was associated with improved survival in patients with resected stage I lung cancer.(6) High expression of IGF-1R is associated with poor survival in surgically resected stage I lung cancer, specifically adenocarcinoma subtype. Patients with adenocarcinoma and never smoker had higher expression of IGF-1R vs. squamous cell carcinoma and smokers.(7). Low IGF-1R expression was associated with significant improvement in survival in the adenocarcinoma lung cancer but there was a lack of correlation between expression of IGF1R and survival in patients with squamous cell histology. Monoclonal antibodies target the extracellular domain of IGF-IR and small molecules inhibit IGF-1R kinase. This is a potential new strategy in the treatment of lung cancer.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Arm A: Pemetrexed Cisplatin	Pemetrexed: 500mg/m2 IV on day 1 and Cisplatin: 75 mg/m2 IV on day 1 every 21 days x 6 cycles.
DRUG	Arm B Pemetrexed, Cisplatin and MK-0646	Pemetrexed 500 mg/m2 IV on Day 1 and Cisplatin 75 mg/m2 IV on Day 1 every 21 days for 6 cycles in combination with MK-0646 will be given IV, 10 mg/KG, Days 1, 8 and 15 weekly.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-02-01
• Completion: 2014-07-01
• First posted: 2008-11-27
• Last updated: 2014-11-07

Locations

4 sites across 1 country: United States