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Non-Small Cell Lung CancerPhase 2NCT00741988

Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

A Phase 2 study testing Ixabepilone, Carboplatin and Bevacizumab in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Ixabepilone, Carboplatin and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
13 sitesUnited States
Study dates
Sep 2008to Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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
  • Creatinine <=2.0 mg/dL or
  • Calculated (measured) GFR >=40 mL/min
  • PT/INR and PTT <=1.5 x ULN
  • Peripheral neuropathy <= grade 1.

Who cannot join

  • 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.
  • Exclusion Criteria for Enrollment on Bevacizumab (Cohort B):
Show all 18Show fewer
  • 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
  • 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).
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Gainsville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Dr. Donald Berdeaux

    Great Falls, Montana, 59405

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: Phase II Trial of Ixabepilone and Carboplatin With or Without Bevacizumab in Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer

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).

Read the detailed description

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.

Being tested
Ixabepilone, Carboplatin, Bevacizumab
Keywords
Non-Small Cell Lung Cancer, Advanced Disease, Untreated, Ixabepilone, Carboplatin, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxabepiloneDrug

    Also called Ixempra

    ixabepilone 30 mg/m2

  • CarboplatinDrug

    Also called Paraplatin, Paraplatin-AQ

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

  • BevacizumabDrug

    Also called Avastin

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

Study groups in NCT00741988
Study groupRoleWhat they receive
Cohort AExperimentalixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Receives: Drug: Ixabepilone; Drug: Carboplatin
Cohort BExperimentalixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Receives: Drug: Ixabepilone; Drug: Carboplatin; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months

Secondary outcomes (3)

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

    Measured: 18 months

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

    Measured: 18 months

  3. Number of Participants Experiencing Treatment Related Toxicity

    Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here. Toxicities that were occurring >=5% of total patients are listed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2010
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741988
Sponsor's protocol ID
SCRI LUN 179
Status last verified
Dec 2021
First submitted
25 Aug 2008
Last updated
15 Dec 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 22947511

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixabepilone, Carboplatin and Bevacizumab in people with Non-Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.

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