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Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer (NRR)

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00454324
First received: March 28, 2007
Last updated: May 9, 2017
Last verified: May 2017
  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: Carboplatin Drug: Abraxane Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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 UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 12 weeks ]
    Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Overall Response Rate = CR+PR.


Secondary Outcome Measures:
  • 1-year Overall Survival (OS) [ Time Frame: every 12 weeks for 1 year ]
    Percentage of participants from the start of treatment with the disease that are still alive.

  • Progression Free Survival (PFS) [ Time Frame: Through the end of the study, an average of approximately 8 months ]
    Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact

  • Number of Individuals With Adverse Events [ Time Frame: 10 weeks ]
    Drug toxicities will be evaluated during treatment period and 30 days post treatment. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) criteria. Grade 3 or 4 adverse events were reported


Enrollment: 30
Study Start Date: April 2006
Study Completion Date: December 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Drug: Carboplatin
Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle
Other Name: Paraplatin
Drug: Abraxane

Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)

Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)

Other Name: Paclitaxel
Experimental: Arm B
Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Drug: Carboplatin
Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle
Other Name: Paraplatin
Drug: Abraxane

Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)

Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)

Other Name: Paclitaxel

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454324

Locations
United States, North Carolina
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Thomas Stinchcombe, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00454324     History of Changes
Obsolete Identifiers: NCT00521313
Other Study ID Numbers: LCCC 0519
CDR0000542753 ( Other Identifier: PDQ number )
Study First Received: March 28, 2007
Results First Received: March 23, 2017
Last Updated: May 9, 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Lung cancer
Small cell lung cancer
Abraxane
Paclitaxel
Carboplatin
Phase II
Randomized
Lineberger
LCCC

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017