Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion 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.

Exclusion 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)