CompletedPhase 2NCT00741988
Official study title

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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIxabepilone and Carboplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 15, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?SCRI Development Innovations, LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SCRI Development Innovations, LLC
Interventions being studied
Drug: Ixabepilone; Drug: Carboplatin; Drug: Bevacizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. 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. 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.
Reasons someone may not be able to joinExclusion criteria

1. 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. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer SpecialistsFort Myers, Florida
  • Gainsville Hematology Oncology AssociatesGainesville, Florida
  • Providence Medical GroupTerre Haute, Indiana
  • Consultants in Blood Disorders and CancerLouisville, Kentucky
  • Center for Cancer and Blood DisordersBethesda, Maryland
  • Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan
  • Research Medical CenterKansas City, Missouri
  • Dr. Donald BerdeauxGreat Falls, Montana
  • Oncology Hematology CareCincinnati, Ohio
  • South Carolina Oncology AssociatesColumbia, South Carolina
  • Spartanburg Regional Medical CenterSpartanburg, South Carolina
  • Tennessee Oncology, PLLCNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 15, 2021. Always confirm current availability with the study team.

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