PhII ICb With/Without Erbitux in MBC Pts

NCT00248287

Last updated date
Study Location
Birmingham Hematology and Oncology
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Metastatic Breast CancerPhII ICb With/Without Erbitux in MBC Pts
NCT00248287
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Sedona, Arizona
  4. Denver, Colorado
  5. Torrington, Connecticut
  6. Melbourne, Florida
  7. New Port Richey, Florida
  8. Ocala, Florida
  9. Ocoee, Florida
  10. Chicago, Illinois
  11. Indianapolis, Indiana
  12. Overland Park, Kansas
  13. Columbia, Maryland
  14. Minneapolis, Minnesota
  15. Columbia, Missouri
  16. Saint Louis, Missouri
  17. Las Vegas, Nevada
  18. Hooksett, New Hampshire
  19. Morristown, New Jersey
  20. Summit, New Jersey
  21. Albany, New York
  22. Rexford, New York
  23. Rochester, New York
  24. Cary, North Carolina
  25. Kettering, Ohio
  26. Eugene, Oregon
  27. Seneca, South Carolina
  28. Abilene, Texas
  29. Arlington, Texas
  30. Austin, Texas
  31. Beaumont, Texas
  32. Bedford, Texas
  33. Dallas, Texas
  34. Dallas, Texas
  35. Dallas, Texas
  36. Dallas, Texas
  37. Denton, Texas
  38. El Paso, Texas
  39. Fort Worth, Texas
  40. Fredericksburg, Texas
  41. Houston, Texas
  42. Longview, Texas
  43. McAllen, Texas
  44. Mesquite, Texas
  45. Midland, Texas
  46. New Braunfels, Texas
  47. Odessa, Texas
  48. Paris, Texas
  49. Sherman, Texas
  50. Sugar Land, Texas
  51. Tyler, Texas
  52. Waco, Texas
  53. Norfolk, Virginia
  54. Salem, Virginia
  55. Edmonds, Washington
  56. Seattle, Washington
  57. Spokane, Washington
  58. Vancouver, Washington
  59. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PhII ICb With/Without Erbitux in MBC Pts
Official Title  ICMJE Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Irinotecan + Carboplatin
    irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
  • Drug: irinotecan + Carboplatin + erbitux
    irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2
Study Arms  ICMJE
  • Active Comparator: Arm 1
    irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)
    Intervention: Drug: Irinotecan + Carboplatin
  • Experimental: Arm 2
    irinotecan 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)
    Intervention: Drug: irinotecan + Carboplatin + erbitux
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 28, 2007)
154
Original Enrollment  ICMJE
 (submitted: November 2, 2005)
120
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date May 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

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.

  • 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).

EXCLUSION CRITERIA:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248287
Other Study ID Numbers  ICMJE 04070
CA225200 ( Other Identifier: Bristol-Myers-Squibb )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party US Oncology Research
Study Sponsor  ICMJE US Oncology Research
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Pfizer
Investigators  ICMJE
Principal Investigator:Joyce A. O'Shaughnessy, MDUS Oncology Research
PRS Account US Oncology Research
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP