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Extensive-Stage Small Cell Lung CancerPhase 2NCT01076504

A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

A Phase 2 study testing Amrubicin, Carboplatin and Pegfilgrastim in people with Extensive-Stage Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-Stage Small Cell Lung Cancer
What is being tested?
Amrubicin, Carboplatin and Pegfilgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
20 sitesUnited States
Study dates
Dec 2009to Mar 2015
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

  • Cytologically and/or histologically confirmed small-cell lung cancer with extensive stage disease.
  • Measurable or evaluable disease per RECIST criteria version 1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).
  • QTc interval of ≤450 msec. on ECG.
  • Adequate organ function, including the following:
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  • ANC ≥1500 cells/micro liter
  • Platelet count ≥100,000 cells/micro liter
  • Hemoglobin ≥9 g/dL
  • Total bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN, (except if due to hepatic metastases, then ≤5 x ULN)
  • Serum creatinine ≤1.5 x ULN
  • Patients must be able to receive growth factors (G-CSF).
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patients ≥18 years of age.
  • Patients must be accessible for treatment and follow-up.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Who cannot join

  • Previous treatment for limited-stage SCLC.
  • Previous chemotherapy or radiation therapy for SCLC (unless radiation was administered for brain metastases).
  • Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed ≥ 21 days prior to first dose of amrubicin; (2) follow-up scan shows no disease progression; an absence of neurologic symptoms and (3) patient does not require steroids.
  • Mixed small cell/non-small cell tumors or other neuroendocrine lung cancers.
  • Women who are pregnant or breastfeeding.
  • Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
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  • Patients with New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
  • Any of the following ≤6 months prior to starting study treatment:
  • myocardial infarction;
  • severe unstable angina;
  • ongoing cardiac dysrhythmia.
  • Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.
  • Treatment for other invasive cancers during the previous 5 years, or the presence of any active invasive cancer of any type (with the exception of non-melanoma skin cancers).
  • Uncontrolled hypertension (i.e., blood pressure >150/90 mmHg that cannot be controlled with standard anti-hypertensive agents).
  • Major surgical procedure or significant traumatic injury ≤ 28 days of study initiation.
  • History of seropositive HIV or patients who are receiving immunosuppressive medications that would in the opinion of the investigator increase the risk of the serious neutropenic complications.
  • Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • Use of any non-approved or investigational agent ≤30 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Hematology Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70806

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

Other trials in United States

About this study

Official title: A Phase II Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer

This proposed trial will investigate the combination of amrubicin and carboplatin in the first-line treatment of patients with extensive-stage small cell lung cancer (ES- SCLC). Since myelosuppression is the most common toxicity produced by this drug combination, pegfilgrastim will be administered with each treatment cycle. This trial will be the first clinical trial to evaluate a combination of amrubicin and carboplatin in the first-line treatment of ES SCLC in a U.S. population.

Being tested
Amrubicin, Carboplatin, Pegfilgrastim
Keywords
SCLC, Amrubicin, Carboplatin, Pegfilgrastim, Neulasta
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • AmrubicinDrug

    Also called SM-5887

    30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle

  • CarboplatinDrug

    Also called cis-Diammine, Paraplatin, Paraplatin-AQ

    AUC=5 IV, Day 1 of each 3-week treatment cycle

  • PegfilgrastimDrug

    Also called Neulasta

    6 mg SQ on Day 4 of each 3 week treatment cycle

Study groups in NCT01076504
Study groupRoleWhat they receive
Amrubicin/Carboplatin with PegfilgrastimExperimentalSystemic therapy
Receives: Drug: Amrubicin; Drug: Carboplatin; Drug: Pegfilgrastim

What is being measured

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

  1. 1-year Survival

    Percentage of patients still alive one year after their first treatment

    Measured: 12 months

Secondary outcomes (4)

  1. Objective Response Rate

    The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: 36 months

  2. Time to Progression

    Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: 36 months

  3. Overall Survival

    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 84 months

  4. Toxicity/Safety

    Grade 3/4 toxicities

    Measured: 36 months

Timeline

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

  1. First posted26 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionMar 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076504
Sponsor's protocol ID
SCRI LUN 199
Status last verified
Apr 2016
First submitted
8 Dec 2009
Last updated
5 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amrubicin, Carboplatin and Pegfilgrastim in people with Extensive-Stage Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 20 sites 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 16 inclusion and 19 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: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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 10 Dec 2015). 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?

1-year Survival (time frame: 12 months). 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 NCT01076504.

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 5 May 2016.

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