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Small Cell Lung CancerPhase 2NRRNCT00454324

Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

A Phase 2 study testing Carboplatin and Abraxane in people with Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Carboplatin and Abraxane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2006to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of extensive stage small-cell lung cancer (ES-SCLC),* including malignant pleural effusion
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC
  • Measurable disease as defined by the RECIST criteria
  • Adequate organ function as defined by the protocol
  • Female patients of child bearing potential (CBP) must agree to use of reliable method of birth control during and for 3 months following treatment
Show all 11Show fewer
  • Patients must sign informed consent document
  • Patients must be ≥ 18 years of age
  • Patients with brain metastases that have been adequately treated and are determined to be controlled by the attending physician are eligible
  • 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.

Who cannot join

  • 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
  • Pregnancy or breast feeding
  • 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
  • Symptomatic brain metastases
  • Grade ≥ 2 neuropathy using NCI CTCAE version 3.0 criteria
  • Previous anaphylactic reaction to carboplatin, paclitaxel, and docetaxel
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599-7295

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Carboplatin, Abraxane
Keywords
Lung cancer, Small cell lung cancer, Abraxane, Paclitaxel, Carboplatin, Phase II, Randomized, Lineberger, LCCC
Medical subject headings
Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Paraplatin

    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

  • AbraxaneDrug

    Also called Paclitaxel

    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)

Study groups in NCT00454324
Study groupRoleWhat they receive
Arm AExperimentalCarboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles
Receives: Drug: Carboplatin; Drug: Abraxane
Arm BExperimentalCarboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles
Receives: Drug: Carboplatin; Drug: Abraxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    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.

    Measured: 12 weeks

Secondary outcomes (3)

  1. 1-year Overall Survival (OS)

    Percentage of participants from the start of treatment with the disease that are still alive.

    Measured: every 12 weeks for 1 year

  2. Progression Free Survival (PFS)

    Defined as the time between trial enrollment to disease progression or death (whichever occurs first) or date of last contact

    Measured: Through the end of the study, an average of approximately 8 months

  3. Number of Individuals With Adverse Events

    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

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2007 (estimated)
  2. Study startApr 2006
  3. Primary completionJul 2010
  4. Study completionDec 2014

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00454324
Sponsor's protocol ID
LCCC 0519
Other IDs
CDR0000542753
Acronym
NRR
Status last verified
Jun 2017
First submitted
28 Mar 2007
Last updated
11 Jul 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25616430

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin and Abraxane in people with Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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