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

Part of paid clinical trials in Lakeland, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00499109
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    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
  • Vinorelbine — DRUG
    DV Group: 35 mg/m\^2 on days 1 and 15
  • Carboplatin — DRUG
    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.
  • Gemcitabine — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Jun 2014
Primary completion
Apr 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
275 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: E. Dual Agent Chemotherapy
    Experimental Arm E. Patients received treatment according to gene expression strata with four doublet regimens. Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group. Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group. High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group. High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group.
  • Active Comparator: C. Standard of Care Control Arm
    Control Arm C: Gemcitabine and Carboplatin (GCb). All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 6 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Center for Cancer Care & Research/WatsonLakelandFlorida33805-
Leesburg Regional Medical CenterLeesburgFlorida34748-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Johns Hopkins Sidney Kimmell Comprehensive Cancer CenterBaltimoreMaryland21231-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Southeast Nebraska Cancer CenterLincolnNebraska68510-2496-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2947-

Find similar trials in Lakeland, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Center for Cancer Care & Research/Watson· Lakeland, FLLeesburg Regional Medical Center· Leesburg, FLH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLJohns Hopkins Sidney Kimmell Comprehensive Cancer Center· Baltimore, MDBarbara Ann Karmanos Cancer Institute· Detroit, MISoutheast Nebraska Cancer Center· Lincoln, NE

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