Phase II Trial of Ixabepilone and Carboplatin With or Without Bevacizumab in Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer
The trial will include a lead-in phase for each cohort to assess safety. In Cohort A, 10
patients will receive ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day
1 of one 21-day treatment cycle. If no unexpected toxicities occur, Cohort A will open to
enrollment. Enrollment for Cohort A will be done in two stages (after the lead-in portion
is completed). The first stage for Cohort A will enroll a total of 22 patients (this will
include the 10 patients from the lead-in phase). If there are at least 3 responses during
stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional
patients will be enrolled (for a total of 39 patients in Cohort A). During stage 1 and
stage 2, patients in Cohort A will receive treatment with ixabepilone 30 mg/m2 and
carboplatin AUC = 6 intravenously (IV) on Day 1 of each 21-day treatment cycle. Treatment
will continue until disease progression or unacceptable toxicity occurs.
After the lead-in phase for Cohort A is completed, a similar lead-in portion, also
consisting of 10 patients, will be done for Cohort B. Patients in Cohort B will receive
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on
Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur in this group,
Cohort B will open to enrollment. Enrollment for Cohort B will also be done in two stages
(after the lead-in portion is completed). The first stage for Cohort B will enroll a total
of 22 patients (this will include the 10 patients from the lead-in phase). If there are at
least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the
study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort B).
During stage 1 and stage 2, patients in Cohort B will receive treatment with ixabepilone 30
mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of each
21-day treatment cycle. Treatment will continue until disease progression or unacceptable
toxicity occurs.
Unexpected toxicities include any grade 4 hematologic toxicity or grade 3/4 non hematologic
toxicity that does not reverse within 7 days in more than 2 patients.
Eligible patients will receive ixabepilone, carboplatin, and bevacizumab (bevacizumab will
be administered to patients in Cohort B only) at 21-day intervals. Patients will be re
evaluated every 6 weeks using computerized tomography (CT) scans. Response to therapy will
be assigned using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al.
2000) (see Section 7). Patients who have objective response or stable disease will continue
treatment for 6 cycles, until the time of tumor progression or intolerable treatment-related
side effects. Patients in Cohort B without progressive disease will be eligible to receive
bevacizumab monotherapy for 6 additional cycles, or until undue toxicity or tumor
progression occurs.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
The Percentage of Patients Who Experience an Objective Benefit From Treatment
18 months
No
David R Spigel, MD
Study Chair
Sarah Cannon Research Insititute
United States: Institutional Review Board
SCRI LUN 179
NCT00741988
September 2008
September 2012
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Research Medical Center | Kansas City, Missouri 64132 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Gainsville Hematology Oncology Associates | Gainesville, Florida 32605 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Dr. Donald Berdeaux | Great Falls, Montana 59405 |