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 EscalationPemetrexed: 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tuscon | Arizona | 85724 | - |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | - |
| Providence Cancer Center | Portland | Oregon | 97213 | - |
| Cancer Research And Biostatistics Clinical Trials Consortium | Seattle | Washington | 98101 | - |
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