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

Primary Purpose

Small Cell Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Abraxane

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Lung cancer, Small cell lung cancer, Abraxane, Paclitaxel, Carboplatin, Phase II, Randomized, Lineberger, LCCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Sites / Locations

University of North Carolina Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1-year Overall Survival (OS)

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

Progression Free Survival (PFS)

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

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

Full Information

NCT ID

NCT00454324

First Posted

March 28, 2007

Last Updated

June 9, 2017

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00454324

Brief Title

Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

Acronym

NRR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

slow accrual

Study Start Date

April 2006 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

Lung cancer, Small cell lung cancer, Abraxane, Paclitaxel, Carboplatin, Phase II, Randomized, Lineberger, LCCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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

Arm Title

Arm B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Abraxane

Other Intervention Name(s)

Paclitaxel

Intervention Description

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)

Primary Outcome Measure Information:

Title

Overall Response Rate

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

1-year Overall Survival (OS)

Description

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

Time Frame

every 12 weeks for 1 year

Title

Progression Free Survival (PFS)

Description

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

Time Frame

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

Title

Number of Individuals With Adverse Events

Description

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Stinchcombe, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7295

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25616430

Citation

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.

Results Reference

derived

Links:

URL

http://unclineberger.org

Description

UNC Lineberger Comprehensive Cancer Center

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Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer

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