Study of Everolimus, Pemetrexed, Carboplatin, and Bevacizumab to Treat Stage IV Lung Cancer

Part of paid clinical trials in Tuscon, Arizona.

Sponsor
Cancer Research and Biostatistics Clinical Trials Consortium
Study ID
NCT01700400
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Everolimus — DRUG
  • Pemetrexed — DRUG
  • Carboplatin — DRUG
  • Bevacizumab — DRUG

Study Details

The purpose of this study is to determine whether the investigational study drug everolimus may be used to increase the effectiveness of chemotherapy treatment for patients with advanced lung cancer.

Key Dates

First listed
Oct 4, 2012
Start date
Sep 30, 2012
Status verified
May 2014
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Phase I Dose Escalation
    Pemetrexed: intravenous; 500 mg/m² for Dose Levels 1, 2 and 3 Carboplatin: intravenous; 5 AUC for Dose Level 1; 6 AUC for Dose Levels 2 and 3 Bevacizumab: intravenous; 15 mg/kg for Dose Levels 1, 2, and 3 Everolimus: oral, 2.5 mg/day for Dose Levels 1 and 2; 5.0 mg/day for Dose Level 3

Primary Outcome Measure

Define the Maximum Tolerated Dose (MTD) and Recommended Phase Two Dose (RPTD) of the combination of everolimus with pemetrexed, carboplatin, and bevacizumab in patients with Stage IV non-squamous NSCLC. [ Time Frame: up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTusconArizona85724-
University of Kentucky Markey Cancer CenterLexingtonKentucky40536-
Providence Cancer CenterPortlandOregon97213-
Cancer Research And Biostatistics Clinical Trials ConsortiumSeattleWashington98101-

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