Clinical trial NCT00454324: Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
Official title: Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Lung cancer
Small cell lung cancer
Abraxane
Paclitaxel
Carboplatin
Phase II
Randomized
Lineberger
LCCC
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2007-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients are being asked to be in this study because they have extensive disease small cell lung cancer. All eligible participants who agree to be in the study will receive both abraxane and carboplatin. The researchers want to evaluate the activity and safety of the combination of abraxane and carboplatin, and if this combination can help people with extensive disease small cell lung cancer.

Carboplatin is a chemotherapy drug that has been approved by the Food and Drug Administration (FDA) to treat ovarian cancer. It is in a class of drugs known as platinum-containing compounds. It slows or stops the growth of cancer cells in your body. Carboplatin is not approved by the FDA for use in the treatment of small-cell lung cancer, either alone or combined with other anti-cancer drugs. However, carboplatin given with paclitaxel is a standard or active treatment in patients with small cell lung cancer, non-small cell lung cancer, breast cancer, and ovarian cancer. Abraxane is a chemotherapy drug that was approved by the FDA to treat metastatic breast cancer after other chemotherapy has already been tried. Abraxane is a new preparation of the active ingredient in the chemotherapy drug, paclitaxel. In a study done in breast cancer patients, Abraxane was compared to paclitaxel. Abraxane has been shown to be more effective than paclitaxel in tumor response and tumor progression, in addition to having fewer side effects than paclitaxel. Abraxane was shown to cause less damage to a person's white blood cells (the cells that fight infection) and cause fewer allergic reactions; however, more patients developed numbness of their hands and feet.

Carboplatin and Abraxane are intravenous (IV) medications. Patients will begin treatment with 2 cycles (1 cycle = 21 days) of abraxane and carboplatin. Then there will be a disease assessment at cycles 2 and 4. Patients with stable disease, partial response, or complete response will get additional cycles. Patients with progressive disease no will be taken off the study treatment. A maximum of 6 cycles will be given.

Eligibility 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)

Primary outcomes:
measure: Overall Response Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: 1-year Overall Survival (OS)
timeFrame: every 12 weeks for 1 year
measure: Progression Free Survival (PFS)
timeFrame: Through the end of the study, an average of approximately 8 months
measure: Number of Individuals With Adverse Events
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Thomas Stinchcombe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grilley-Olson JE, Keedy VL, Sandler A, Moore DT, Socinski MA, Stinchcombe TE. A randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (abraxane) in patients with extensive-stage small cell lung cancer. Oncologist. 2015 Feb;20(2):105-6. doi: 10.1634/theoncologist.2014-0327. Epub 2015 Jan 23.