Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer
NCT ID: NCT00741988
Last Updated: 2021-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2008-09-30
2012-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Ixabepilone
ixabepilone 30 mg/m2
Carboplatin
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Cohort B
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Ixabepilone
ixabepilone 30 mg/m2
Carboplatin
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Bevacizumab
bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Interventions
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Ixabepilone
ixabepilone 30 mg/m2
Carboplatin
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Bevacizumab
bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy
3. Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
4. Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
5. Male or female patients \>=18 years of age.
6. Life expectancy of at least 3 months.
7. ECOG performance status of \<=1.
8. Measurable disease by RECIST criteria (see Section 7).
9. Laboratory values as follows:
* ANC \>=1500/mm3 (7 days prior to treatment);
* Hemoglobin \>=8 g/dL;
* Platelets \>=100,000 mm3 (7 days prior to treatment)
* Bilirubin \<=1 x ULN for institution
* AST/SGOT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases and
* ALT/SGPT \<=2.5 x ULN or \<=5.0 x ULN in patients with liver metastases
* Creatinine \<=2.0 mg/dL or
* Calculated (measured) GFR \>=40 mL/min
* PT/INR and PTT \<=1.5 x ULN
10. Peripheral neuropathy \<= grade 1.
Exclusion Criteria
2. Metastatic brain or meningeal tumors.
3. Uncontrolled intercurrent illness.
4. Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
5. Patient is \<=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
1. Patients with squamous cell histology NSCLC.
2. Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.
3. Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.
4. Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.
5. Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.
6. Patients with serious non-healing wound, ulcer, or bone fracture.
7. Patients with evidence of bleeding diathesis or coagulopathy.
8. Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.
9. Patients with proteinuria at screening, as demonstrated by either:
* Urine protein : creatinine (UPC) ratio \>=1.0 or
* Urine dipstick for protein \>=2+ (patients discovered to have \>=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate \<1 g of protein in 24 hours to be eligible).
10. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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David R Spigel, MD
Role: STUDY_CHAIR
Sarah Cannon Research Insititute
Locations
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Florida Cancer Specialists
Fort Myers, Florida, United States
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States
Providence Medical Group
Terre Haute, Indiana, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Dr. Donald Berdeaux
Great Falls, Montana, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Countries
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References
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Spigel DR, Anthony Greco F, Waterhouse DM, Shipley DL, Zubkus JD, Bury MJ, Webb CD, Hart LL, Gian VG, Infante JR, Burris HA 3rd, Hainsworth JD. Phase II trial of ixabepilone and carboplatin with or without bevacizumab in patients with previously untreated advanced non-small-cell lung cancer. Lung Cancer. 2012 Oct;78(1):70-5. doi: 10.1016/j.lungcan.2012.06.008. Epub 2012 Sep 1.
Other Identifiers
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SCRI LUN 179
Identifier Type: -
Identifier Source: org_study_id