NCT00454324

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

4.3 years

First QC Date

March 28, 2007

Results QC Date

March 23, 2017

Last Update Submit

June 9, 2017

Conditions

Small Cell Lung Cancer

Keywords

Lung cancerSmall cell lung cancerAbraxanePaclitaxelCarboplatinPhase IIRandomizedLinebergerLCCC

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (3)

  • 1-year Overall Survival (OS)

    every 12 weeks for 1 year

  • Progression Free Survival (PFS)

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

  • Number of Individuals With Adverse Events

    10 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles

Drug: CarboplatinDrug: Abraxane

Arm B

EXPERIMENTAL

Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles

Drug: CarboplatinDrug: Abraxane

Interventions

CarboplatinDRUG

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

Also known as: Paraplatin
Arm AArm B
AbraxaneDRUG

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)

Also known as: Paclitaxel
Arm AArm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (1)

  • 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.

    PMID: 25616430DERIVED

Related Links

MeSH Terms

Conditions

Small Cell Lung CarcinomaLung Neoplasms

Interventions

CarboplatinAlbumin-Bound PaclitaxelPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Limitations and Caveats

The trial was closed prematurely because of slow accrual before the impact of the dose reduction on toxicity and treatment compliance could be assessed. In arm A, 6 patients required a dose reduction. In arm B, 3 patients required a dose reduction.

Results Point of Contact

Title
Robin V. Johnson
Organization
UNC Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • Thomas Stinchcombe, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 30, 2007

Study Start

April 1, 2006

Primary Completion

July 1, 2010

Study Completion

December 1, 2014

Last Updated

July 11, 2017

Results First Posted

June 12, 2017

Record last verified: 2017-06

Locations

US(1)