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Metastatic Breast CancerPhase 2CA225200NCT00248287

PhII ICb With/Without Erbitux in MBC Pts

A Phase 2 study testing Irinotecan + Carboplatin and irinotecan + Carboplatin + erbitux in people with Metastatic Breast Cancer, run by US Oncology Research at 59 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer. 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?
Irinotecan + Carboplatin and irinotecan + Carboplatin + erbitux
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
59 sitesUnited States
Study dates
28 Jul 2005to Dec 2026
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

  • Male and female patients will be eligible for inclusion in this study if they meet all of the following criteria:
  • Has cytologically or pathologically confirmed, breast cancer with documented HER2+ (positive) (3+ by IHC or FISH+) or HER2- (negative) disease. ER, PR, and HER2 status must be documented in the electronic Case Report Form (eCRF) NOTE: Patients whose breast cancers are HER2 (2+) by IHC must undergo FISH testing to confirm HER2+ (positive) status.
  • Has clinically confirmed Stage IV metastatic breast cancer (MBC)
  • Has undergone prior Herceptin therapy if breast cancer is HER2+ (positive)
  • Has measurable MBC as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
  • NOTE: Ascites, pleural effusion, and bone metastases are not considered measurable.
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  • Has had up to 1 prior chemotherapy regimens for metastatic disease. Previously untreated disease is permitted.
  • Has had no prior treatment with irinotecan, carboplatin, or cisplatin
  • Has an ECOG Performance Status (PS) 0-2
  • Is greater than 18 years of age
  • Please see protocol for specific details regarding appropriate laboratory values for inclusion to the study.
  • Any prior radiation therapy has been completed > 2 weeks prior to the start of study treatment
  • NOTE: Previously irradiated lesions will not be evaluable; however, these patients will still be eligible. Patients must have at least 1 measurable lesion at baseline.
  • Has had a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential). A pregnancy test is also required within 7 days of Dose 1.
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 6 months thereafter.
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form (HIPAA)
  • Has paraffin-embedded breast cancer tissue (either paraffin blocks or 20 unstained slides) available for analysis of EGFR, cytokeratin, and other biological markers. These samples will be sent to the Molecular Profiling Institute (MPI; see Appendix VII).
  • NOTE: Availability of samples should be confirmed prior to randomization (at latest, prior to first dose).

Who cannot join

  • Has Stage I-III breast cancer or nonmeasurable metastatic breast cancer, or any disease other than that described in inclusion criterion #1
  • Has received prior treatment with irinotecan, carboplatin, or cisplatin
  • Is receiving any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)
  • Has received prior therapy which specifically and directly targets the EGFR pathway. Prior Herceptin is required for HER2+ patients.
  • Has had prior severe infusion reaction to a monoclonal antibody
  • Has received organ allograft(s) other than corneal, bone, or skin
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  • Has clinically significant uncontrolled cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmias not well-controlled with medication) or has had a myocardial infarction < 12 months
  • Has ongoing peripheral neuropathy > Grade I
  • Has evidence of symptomatic or untreated central nervous system (CNS) metastases (unless CNS metastases have been irradiated). Chronic steroid treatment for the treatment of CNS metastases must have been discontinued for greater than 4 weeks prior to study enrollment.
  • Has any other significant comorbidity that, in the opinion of the clinical investigator, might compromise any aspect of the study
  • Has active or uncontrolled infection
  • Has acute hepatitis or is known to be HIV positive
  • Has a history of other malignancy within the last 5 years which could affect the diagnosis or assessment of MBC, with the exception of carcinoma of the cervix in situ, carcinoma of the bladder in situ, and basal cell carcinoma
  • Has previously completed a chemotherapy regimen within 3 weeks prior to the start of study treatment, or has related toxicities unresolved prior to the start of study treatment
  • NOTE: If patient was receiving prior weekly or daily chemotherapy, he/she may begin study therapy 2 weeks after stopping prior therapy provided all toxicities have resolved; peripheral neuropathy must be less than Grade I as per exclusion criterion #8 above.
  • Has had major surgery within 3 weeks from the start of study treatment, without complete recovery
  • Has participated in any investigational drug study within 4 weeks preceding the start of study treatment
  • Has received a concurrent immunotherapy or hormonal anticancer agent within 2 weeks prior to the start of the study treatment
  • Is receiving a tyrosine kinase inhibitor (ie, IressaTM)
  • Has had any prior stem cell or bone marrow transplant for any prior hematologic malignancy
  • Is pregnant or lactating
  • Is unable to comply with the requirements of the study

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Texas Cancer Center-Abilene(South)

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, P.A. - Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • Hematology Oncology Associates of IL

    Chicago, Illinois, 60611

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • The Texas Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Oncology Center - Denton

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Rose

    Denver, Colorado, 80220

  • Puget Sound Cancer Center-Emonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • San Antonio Tumor & Blood Clinic

    Fredericksburg, Texas, 78624

  • NH Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Central Indiana Cancer Center

    Indianapolis, Indiana, 46227

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Hematology-Oncology Associates of NNJ, P.A.

    Morristown, New Jersey, 07960

  • HOAST - New Braunfels

    New Braunfels, Texas, 78131

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Virginia Oncology Associates

    Norfolk, Virginia, 23505

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Kansas City Cancer-Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Asscociates

    Phoenix, Arizona, 85012

  • New York Oncology Hematology, PC

    Rexford, New York, 12148

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • Onc and Hem Associates of SW VA, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology & Oncology Assoc

    Sedona, Arizona, 86336

  • Cancer Center of the Carolinas, Seneca

    Seneca, South Carolina, 29672

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Arch Medical Services, Inc

    St Louis, Missouri, 63141

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Summit Medical Group

    Summit, New Jersey, 07901

  • Northwestern Connecticut Oncology Hematology Associates

    Torrington, Connecticut, 06790

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Waco Cancer Care and Research Center

    Waco, Texas, 76712

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.

Being tested
Irinotecan + Carboplatin, irinotecan + Carboplatin + erbitux
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Irinotecan + CarboplatinDrug

    irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle

  • irinotecan + Carboplatin + erbituxDrug

    irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2

Study groups in NCT00248287
Study groupRoleWhat they receive
Arm 1Active comparatoririnotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)
Receives: Drug: Irinotecan + Carboplatin
Arm 2Experimentalirinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)
Receives: Drug: irinotecan + Carboplatin + erbitux

What is being measured

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

  1. Objective Response Rates (ORR)

    To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: 2 years

Secondary outcomes (3)

  1. Duration of Response

    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

    Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.

  2. Median Time of 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.

    Measured: 2 years

  3. Median Overall Survival (OS)

    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: 2 years

Timeline

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

  1. First posted3 Nov 2005 (estimated)
  2. Study start28 Jul 2005
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

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
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248287
Sponsor's protocol ID
04070
Other IDs
CA225200
Acronym
CA225200
Status last verified
Jan 2025
First submitted
2 Nov 2005
Last updated
29 Jan 2025

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan + Carboplatin and irinotecan + Carboplatin + erbitux in people with Metastatic Breast Cancer, run by US Oncology Research at 59 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 19 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 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 Rates (ORR) (time frame: 2 years). 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 NCT00248287.

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 29 Jan 2025.

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PhII ICb With/Without Erbitux in MBC Pts (NCT00248287) | AzTrials