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Metastatic Breast CancerPhase 2NCT00303108

Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

A Phase 2 study testing Pegylated liposomal doxorubicin, Carboplatin and trastuzumab in people with Metastatic Breast Cancer, run by US Oncology Research at 57 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Pegylated liposomal doxorubicin, Carboplatin and trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
57 sitesUnited States
Study dates
Dec 2005to Jun 2011
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

  • Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease
  • Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.
  • Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study
  • Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy
  • For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC
  • For taxane-naïve patients, has had no prior chemotherapy for MBC
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  • Has had cumulative doses of < 300 mg/m2 prior doxorubicin or < 450 mg/m2 prior epirubicin
  • Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.
  • Has an ECOG Performance Status (PS) 0-2 (see Appendix I)
  • Is a male or female greater than or equal to 18 years of age
  • Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.
  • Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential [WOCBP; not surgically sterilized and between menarche and 1 year postmenopause])
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form (HIPAA Form)
  • Has a life expectancy of > 3 months

Who cannot join

  • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil
  • Has evaluable only disease; eg, bone only, pleural, peritoneal only disease
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.
  • Is receiving concurrent investigational therapy or has received such therapy within 30 days
  • Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease
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  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is a pregnant or lactating woman
  • Is unable to comply with requirements of study

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Texas Cancer Center - Abilene (South)

    Abilene, Texas, 79606

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Oncology, P.A.-Amarillo

    Amarillo, Texas, 79106

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, PA-Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Raleigh Hematology Oncology Associates

    Cary, North Carolina, 27511

  • Hematology Oncology Associates of IL

    Chicago, Illinois, 60611

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, PA

    Dallas, Texas, 75231

  • The TexasCancer Center

    Dallas, Texas, 75237

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Texas Cancer Center-Denton

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Rose

    Denver, Colorado, 80220

  • Puget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Vallejy Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern VA Hem-Onc PC

    Fairfax, Virginia, 22031

  • Texas Oncology, PA

    Fort Worth, Texas, 76104

  • Texas Oncology, PA

    Garland, Texas, 75042

  • Texas Oncology, PA

    Houston, Texas, 77024

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Alison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Ruth Oratz MD

    New York, New York, 10016

  • Cancer Care & Hematology Specialists of Chicagoland, PC

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Onc and Hem Associates of SW VA, Inc

    Salem, Virginia, 24153

  • HOAST-Medical Dr.

    San Antonio, Texas, 78229

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology & Oncology Associates-Sedona

    Sedona, Arizona, 86336

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-North

    Spokane, Washington, 99218

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research Center-Waco

    Waco, Texas, 76712

  • Texas Oncology, P.A.

    Webster, Texas, 77598

  • Flavio Kruter, MD, PA

    Westminster, Maryland, 21157

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).

Being tested
Pegylated liposomal doxorubicin, Carboplatin, trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Pegylated liposomal doxorubicinDrug

    Also called Doxil

    30 mg/m2 IV on Day 1 of each 28 day cycle

  • CarboplatinDrug

    AUC=5 on Day 1 of each 28 day cycle

  • trastuzumabDrug

    Also called Herceptin

    4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Study groups in NCT00303108
Study groupRoleWhat they receive
Arm 1ExperimentalPatients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Carboplatin; Drug: trastuzumab

What is being measured

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

  1. Objective Response Rate (ORR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.

Secondary outcomes (3)

  1. Duration of Response

    Duration from date of stating treatment to the date of first CR or PR.

    Measured: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.

  2. Progression-free Survival (PFS)

    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

    Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel.

    Measured: 30 months

  3. 1-year Overall Survival

    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: 1 year

Timeline

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

  1. First posted15 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionMar 2010
  4. Study completionJun 2011

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
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303108
Sponsor's protocol ID
04111
Status last verified
Sep 2016
First submitted
13 Mar 2006
Last updated
3 Nov 2016

Publications

  • Collea RP, Kruter FW, Cantrell JE, George TK, Kruger S, Favret AM, Lindquist DL, Melnyk AM, Pluenneke RE, Shao SH, Crockett MW, Asmar L, O'Shaughnessy J. Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study. Ann Oncol. 2012 Oct;23(10):2599-2605. doi: 10.1093/annonc/mds052. Epub 2012 Mar 19.

    PubMed 22431702

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated liposomal doxorubicin, Carboplatin and trastuzumab in people with Metastatic Breast Cancer, run by US Oncology Research at 57 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 10 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 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 3 Nov 2016). 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?

Objective Response Rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 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 NCT00303108, which also lists 1 linked publication.

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 3 Nov 2016.

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