TerminatedPhase 2NCT00454324
Official study title

Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

Study summary

This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung cancer to examine overall response rate, time to progressive disease, survival time, and assessment of toxicity profile for Carboplatin and Abraxane.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCarboplatin and Abraxane

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 11, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Drug: Carboplatin; Drug: Abraxane
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. Histological or cytological diagnosis of extensive stage small-cell lung cancer (ES-SCLC),\
  • including malignant pleural effusion 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 3. No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC 4. Measurable disease as defined by the RECIST criteria 5. Adequate organ function as defined by the protocol 6. Female patients of child bearing potential (CBP) must agree to use of reliable method of birth control during and for 3 months following treatment 7. Patients must sign informed consent document 8. Patients must be ≥ 18 years of age 9. Patients with brain metastases that have been adequately treated and are determined to be controlled by the attending physician are eligible 10. Patients who have had prior malignancies are eligible if they are ≥ 5 years from diagnosis free of disease or the attending physician believes the patient's prognosis is best defined by the ES-SCLC (if questions concerning this eligibility criteria arise, please contact the principal investigator) (\*)ES-SCLC defined as metastases outside the chest, pulmonary metastases, or contralateral metastases (supraclavicular or hilar) nodes that could not be included with a reasonable single radiation port. Patients with malignant pleural effusions are considered extensive stage.
Reasons someone may not be able to joinExclusion criteria

1. Received treatment within the last 30 days with a drug that has not received Food and Drug Administration (FDA) approval for any indication at the time of study entry 2. Pregnancy or breast feeding 3. Serious active infection that would require a prolonged course (4-6 weeks) of antibiotics or would compromise the safety of the patient or compromise the patient's ability to complete the study 4. Symptomatic brain metastases 5. Grade ≥ 2 neuropathy using NCI CTCAE version 3.0 criteria 6. Previous anaphylactic reaction to carboplatin, paclitaxel, and docetaxel 7. Severe or uncontrolled cardiac disease, defined as uncontrolled or unstable angina, myocardial infarction in the last month, uncontrolled congestive heart failure (≥ 3 admissions for congestive heart failure in the 3 months prior to diagnosis)

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

  • University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2017. Always confirm current availability with the study team.

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