NCT00499109

Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC

Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C). 2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e., standard of care.

Detailed description

Before each cycle, blood tests, vital signs, interim medical history, and a physical exam will be performed. Patients will be carefully checked so that immediate intervention can be initiated should an adverse event (i.e. hypersensitivity) occur. The last treatment cycle according to the study will be cycle #6, or any earlier cycle. Certain tests will be done within 28 days after the last drug infusion. These include physical exam, vital signs, temperature, weight, adverse event evaluation, imaging studies, and blood work. The study doctor will see the participants every 6 to 8 weeks for at least 12 months after they start treatment. After that, the participants will be followed every 3 months for an additional 24 months.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	GD Group: 40 mg/m\^2 on days 1 and 8, every 21 days DCb Group: 75 mg/m\^2 on day 1 DV Group: 50 mg/m\^2 on days 1 and 15, every 28 days
DRUG	Vinorelbine	DV Group: 35 mg/m\^2 on days 1 and 15
DRUG	Carboplatin	GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days DCb Group: AUC 6 on day 1, every 21 days Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.
DRUG	Gemcitabine	GCb Group: 1,250 mg/m\^2 on days 1 and 8 GD Group: 1,250 mg/m\^2 on days 1 and 8 Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.

Timeline

• Start date: 2007-05-01
• Primary completion: 2013-04-01
• Completion: 2013-11-01
• First posted: 2007-07-11
• Last updated: 2014-07-09
• Results posted: 2014-03-26

Locations

9 sites across 3 countries: United States, Germany, Puerto Rico