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Small Cell Lung CancerPhase 2NCT00375193

Study of Amrubicin in Patients With Small Cell Lung Cancer Refractory or Progressive to Prior Therapy

A Phase 2 study testing Amrubicin in people with Small Cell Lung Cancer, run by Celgene at 46 sites in 3 countries.

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

The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease. 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?
Amrubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
46 sitesin 3 countries
Study dates
1 Nov 2006to 1 Mar 2009
Phase
Phase 2
Are there results?
None posted in the registry

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 SCLC; extensive-disease (ED) at time of study entry
  • Refractory to first-line platinum-based chemotherapy (i.e., has received one prior platinum-based chemotherapy regimen) defined as one of the following:
  • Best response to first-line chemotherapy is radiographically documented progression (refractory disease)
  • Best response to first-line chemotherapy is radiographically documented response or stable disease, with subsequent documented progression during continuing chemotherapy (resistant relapse)
  • Documented progression within 90 days of completion of first-line chemotherapy (last dose of chemotherapy), regardless of best response to treatment (resistant relapse)
  • At least 18 years of age
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  • ECOG Performance Status of 0, 1, or 2
  • Measurable disease defined by RECIST criteria
  • Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
  • Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.
  • CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the lesions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
  • Adequate organ function including the following:
  • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9g/dL.
  • Hepatic: bilirubin ≤ 1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 X ULN.
  • Renal: serum creatinine < 2.0 mg/dL or calculated creatinine clearance >60 mL/min.
  • Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA or echocardiography (intra-patient reassessment of LVEF should be performed via the same method throughout the study).
  • Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-bearing potential, use of effective contraceptive methods during the study.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.

Who cannot join

  • Pregnant or nursing women
  • Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to < 25% of the bone marrow.
  • More than 1 prior chemotherapy regiment for SCLC
  • Prior anthracycline treatment
  • Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effecxts of prior therapies, excluding alopecia
  • Patients with secondary primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 2 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time)
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  • Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  • Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for ≥ 2 weeks and off corticosteroids for ≥ 1 week.
  • History of interstitial lung disease or pulmonary fibrosis.

Trial locations and contacts

46 sites in 3 countries.

46 sites in 3 countries

United States44 sites

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Texas Oncology, PA - Bedford

    Bedford, Texas, 76022

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230-2510

  • Texas Oncology, P.A. - Dallas

    Dallas, Texas, 75246

  • Texas Oncology, P.A., Sammons Cancer Center

    Dallas, Texas, 75246

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Texas Oncology, PA - Fort Worth

    Fort Worth, Texas, 76104

  • Northwestern Carolina Oncology & Hematology

    Hickory, North Carolina, 28602

  • Central Indiana Cancer Centers - Indianapolis

    Indianapolis, Indiana, 46227

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • University of Tennessee Medical Center, Knoxville

    Knoxville, Tennessee, 37920

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Rocky Mountain Cancer Center - Sky Ridge

    Lone Tree, Colorado, 80124

  • Norton Healthcare - Louisville Oncology

    Louisville, Kentucky, 40202

  • Minnesota Onc/Hem, PA - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of MN/Division of Hematology, Oncology & Transplantation

    Minneapolis, Minnesota, 55455

  • Sarah Cannon

    Nashville, Tennessee, 37203

  • Cancer Care & Hematology Specialists of Chicago

    Niles, Illinois, 60714

  • Virginia Oncology Associates - Norfolk, VA

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, PA

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Oncology & Hematology of Central Illinois

    Peoria, Illinois, 61602

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Blessing Cancer Center

    Quincy, Illinois, 62301

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27607

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Center

    Seattle, Washington, 98133

  • Arch Medical Group - Arch Medical Services, Inc.

    St Louis, Missouri, 63141

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists - Vancouver Cancer Center

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

  • Texas Oncology, PA - Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Alliance Hematology Oncology, PA - Carroll County Cancer Center

    Westminster, Maryland, 21157

  • Texas Oncology - Wichita Falls

    Wichita Falls, Texas, 76310

  • Yakima Regional Cancer Care Center - North Star Lodge Cancer Center

    Yakima, Washington, 98902

Other trials in United States

Netherlands1 site

  • Free University Medical Center

    Amsterdam, NL 1081 HV

Other trials in Netherlands

United Kingdom1 site

  • Royal Marsden Hospital in Downs Road

    Sutton, Surrey

Other trials in United Kingdom

About this study

Official title: A Phase 2 Trial of Single-Agent Amrubicin in Patients With Extensive Disease Small Cell Lung Cancer That is Refractory or Progressive Within 90 Days of Completion of First Line Platinum-based Chemotherapy

The purpose of the study is to evaluate the objective tumor response rate of amrubicin when administered as second-line therapy to ED-SCLC patients who have refractory or progressive disease.

Being tested
Amrubicin
Keywords
small cell lung cancer, amrubicin
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

    Amrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until Cycle 6 or no longer beneficial

Study groups in NCT00375193
Study groupRoleWhat they receive
1ExperimentalAmrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until cycle 6 or no longer beneficial.
Receives: Drug: Amrubicin

What is being measured

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

  1. Objective tumor response rate according to RECIST

    Measured: Until Disease Progression

Secondary outcomes (8)

  1. Duration of overall response

    Measured: Until Disease Progression

  2. Time to tumor progression

    Measured: Until Disease Progression

  3. Progression free survival

    Measured: Until death or disease progression

  4. Overall survival

    Measured: Until death

  5. Toxicity profile

    Measured: Until 30 days after final dose

  6. Incidence of cardiomyopathy

    Measured: Until end of study participation

  7. Incidence of CNS progression

    Measured: Until disease progression

  8. Pharmacokinetic parameters

    Measured: Cycle 1 only

Timeline

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

  1. First posted12 Sep 2006 (estimated)
  2. Study start1 Nov 2006
  3. Primary completion1 May 2008
  4. Study completion1 Mar 2009

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00375193
Sponsor's protocol ID
CNF3140-SCLC-002
Status last verified
Oct 2019
First submitted
9 Sep 2006
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Ettinger DS, Jotte R, Lorigan P, Gupta V, Garbo L, Alemany C, Conkling P, Spigel DR, Dudek AZ, Shah C, Salgia R, McNally R, Renschler MF, Oliver JW. Phase II study of amrubicin as second-line therapy in patients with platinum-refractory small-cell lung cancer. J Clin Oncol. 2010 May 20;28(15):2598-603. doi: 10.1200/JCO.2009.26.7682. Epub 2010 Apr 12.

    PubMed 20385980

  • Spigel DR, et al. Amrubicin (AMR) and cardiotoxicity in second-line treatment of small cell lung cancer (SCLC): A pooled analysis of left ventricular ejection fraction (LVEF) in two phase II trials. 2009 ASCO Annual Meeting, May 29-June 2, 2009, Chicago, IL. Abstract No.e19019. J Clin Oncol 2009;27(suppl)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amrubicin in people with Small Cell Lung Cancer, run by Celgene at 46 sites in 3 countries.

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 18 inclusion and 9 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Netherlands, United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective tumor response rate according to RECIST (time frame: Until Disease Progression). 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 NCT00375193, which also lists 2 linked publications.

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 24 Oct 2019.

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