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Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), March 2007
First Received: March 28, 2007   Last Updated: August 24, 2007   History of Changes
Sponsors and Collaborators: National Cancer Institute (NCI)
Abraxis BioScience Inc.
UNC Lineberger Comprehensive Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00454324
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Abraxane and Carboplatin
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall Response Rate (complete response + partial response) according to the RECIST criteria

Secondary Outcome Measures:
  • Assess duration of response for responding patients: defined as time from when response was first documented until time when progression was documented
  • Time to progressive disease: defined as interval between trial enrollment and progressive disease or death, whichever occurred first
  • Survival time-median survival time and 1-year survival: defined as time from study enrollment to date of death or date of last follow-up visit
  • Assessment of toxicity profile of carboplatin and Abraxane using the National Cancer Institute Common Toxicity Criteria Adverse Events (NCI CTCAE) version 3.0

Estimated Enrollment: 42
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 paclitaxelin 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 carboplating. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological or cytological diagnosis of 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454324

Contacts
Contact: Maureen Tynan, RN, OCN 919-966-4432 Tynanm@med.unc.edu
Contact: Tammy Allred, RN, OCN 919-966-4432 Tammy_Allred@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
Abraxis BioScience Inc.
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas Stinchcombe, MD The University of North Carolina at Chapel Hill
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000542753, LCCC 0519
Study First Received: March 28, 2007
Last Updated: August 24, 2007
ClinicalTrials.gov Identifier: NCT00454324     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by National Cancer Institute (NCI):
lung cancer
small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antimitotic Agents
Carboplatin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Carboplatin
Antimitotic Agents
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009