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Small Cell Lung CancerPhase 2NCT00319969

Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

A Phase 2 study testing Amrubicin and Topotecan in people with Small Cell Lung Cancer, run by Celgene Corporation at 47 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

The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive. 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 and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
47 sitesUnited States
Study dates
Apr 2006to Jan 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
  • Response to first-line platinum-based chemotherapy
  • Recurrent or progressive SCLC ≥90 days after completion of first-line therapy
  • At least 18 years of age
  • ECOG Performance Status of 0, 1, or 2
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  • 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 leions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (eg., 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 ≥9 g/dL
  • Hepatic: bilirubin ≤1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 X ULN
  • Renal: serum creatinine <2.0mg/dL or calculated creatinine clearance >60mL/min
  • Cardiac: Left ventricular ejection fraction (LVEF) ≥50%
  • Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing 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 regimen for SCLC
  • Prior anthracycline treatment
  • Participation in any investigational drug study within 28 days prior to study entry
  • Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence; prior low grade [Gleason score ≤6] localized prostate cancer is allowed)
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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

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building

    Baltimore, Maryland, 21231

  • Alta Bates Medical Center - Comprehensive Cancer Center

    Berkeley, California, 94704

  • Birmingham Hematology & Oncology

    Birmingham, Alabama, 35205

  • 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, PA

    Dallas, Texas, 75231

  • Texas Oncology - Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center - Denver

    Denver, Colorado, 80218

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Northwestern Carolina Oncology & Hematology

    Hickory, North Carolina, 28602

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • 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

  • Alison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Cancer Care & Hematology Specialists of Chicago

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    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

  • Northwest Cancer Specialists

    Portland, Oregon, 97225

  • Blessing Cancer Center

    Quincy, Illinois, 62301

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Oncology & Hematology Associates of SW Virginia, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Center

    Seattle, Washington, 98133

  • Hematology/Oncology Consultants

    St Louis, Missouri, 63136

  • Arch Medical Services - Center for Cancer Care & Research

    St Louis, Missouri, 63141

  • SUNY Upstate Medical University - Regional Oncology Center

    Syracuse, New York, 13210

  • Hope Center

    Terre Haute, Indiana, 47802

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists - Vancouver Cancer Center

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care & 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

Other trials in United States

About this study

Official title: A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy

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

Being tested
Amrubicin, Topotecan
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 disease progression.

  • TopotecanDrug

    Also called Hycamtin(R)

    Topotecan 1.5mg/m<2> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.

Study groups in NCT00319969
Study groupRoleWhat they receive
1ExperimentalAmrubicin 40mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Receives: Drug: Amrubicin
2Active comparatorTopotecan 1.5mg/m<2> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.
Receives: Drug: Topotecan

What is being measured

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

  1. Objective tumor response rate

    Measured: Until Disease Progression

Secondary outcomes (6)

  1. Time to tumor progression

    Measured: Until Disease Progression

  2. Progression free survival

    Measured: Until death or disease progression

  3. Overall survival (median survival time; 1 year survival)

    Measured: Until death

  4. Toxicity profile

    Measured: Until 30 days after final dose

  5. Incidence of cumulative cardiomyopathy

    Measured: Until end of study participation

  6. Regression of CNS metastases

    Measured: Until disease progression

Timeline

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

  1. First posted27 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionJul 2008
  4. Study completionJan 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00319969
Sponsor's protocol ID
CNF3140-SCLC-05004
Status last verified
Sep 2009
First submitted
27 Apr 2006
Last updated
30 Sep 2009
Results posted
No
Data monitoring committee
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amrubicin and Topotecan in people with Small Cell Lung Cancer, run by Celgene Corporation at 47 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 17 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 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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?

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 (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 NCT00319969.

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 30 Sep 2009.

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