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Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Thomas Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0519

NCT ID:

NCT00454324

Start Date:

April 2006

Completion Date:

June 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Lung cancer
  • Small cell lung cancer
  • Abraxane
  • Paclitaxel
  • Carboplatin
  • Phase II
  • Randomized
  • Lineberger
  • LCCC
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599