NCT00741988

Brief Summary

This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Sep 2008

Typical duration for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 27, 2013

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

August 25, 2008

Results QC Date

January 23, 2013

Last Update Submit

December 13, 2021

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung CancerAdvanced DiseaseUntreatedIxabepiloneCarboplatinBevacizumab

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease

    18 months

  • Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    18 months

  • Number of Participants Experiencing Treatment Related Toxicity

    18 months

Study Arms (2)

Cohort A

EXPERIMENTAL

ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.

Drug: IxabepiloneDrug: Carboplatin

Cohort B

EXPERIMENTAL

ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Drug: IxabepiloneDrug: CarboplatinDrug: Bevacizumab

Interventions

IxabepiloneDRUG

ixabepilone 30 mg/m2

Also known as: Ixempra
Cohort ACohort B
CarboplatinDRUG

carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.

Also known as: Paraplatin, Paraplatin-AQ
Cohort ACohort B
BevacizumabDRUG

bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Also known as: Avastin
Cohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.
  • 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
  • Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
  • 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.
  • Male or female patients \>=18 years of age.
  • Life expectancy of at least 3 months.
  • ECOG performance status of \<=1.
  • Measurable disease by RECIST criteria (see Section 7).
  • 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
  • +4 more criteria

You may not qualify if:

  • A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of \> grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
  • Metastatic brain or meningeal tumors.
  • Uncontrolled intercurrent illness.
  • 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.
  • 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.
  • Patients with squamous cell histology NSCLC.
  • Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.
  • Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.
  • Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.
  • Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.
  • Patients with serious non-healing wound, ulcer, or bone fracture.
  • Patients with evidence of bleeding diathesis or coagulopathy.
  • Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.
  • Patients with proteinuria at screening, as demonstrated by either:
  • Urine protein : creatinine (UPC) ratio \>=1.0 or
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Gainsville Hematology Oncology Associates

Gainesville, Florida, 32605, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Dr. Donald Berdeaux

Great Falls, Montana, 59405, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Related Publications (1)

  • 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.

    PMID: 22947511RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ixabepiloneCarboplatinBevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
John Hainsworth, MD
Organization
Sarah Cannon Research Institute
asksarah@scresearch.net
1-877-691-7274

Study Officials

  • David R Spigel, MD

    Sarah Cannon Research Insititute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2012

Last Updated

December 15, 2021

Results First Posted

February 27, 2013

Record last verified: 2021-12

Locations

US(13)