PhII ICb With/Without Erbitux in MBC Pts (CA225200)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00248287
First received: November 2, 2005
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Irinotecan + Carboplatin
Drug: irinotecan + Carboplatin + erbitux
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Primary objective [ Time Frame: Disease assessment ] [ Designated as safety issue: No ]
    To determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux


Estimated Enrollment: 154
Study Start Date: July 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: Irinotecan + Carboplatin
irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
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)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248287

  Show 59 Study Locations
Sponsors and Collaborators
US Oncology Research
Bristol-Myers Squibb
Pfizer
Investigators
Principal Investigator: Joyce A. O'Shaughnessy, MD US Oncology Research
  More Information

No publications provided

Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00248287     History of Changes
Other Study ID Numbers: 04070, CA225200
Study First Received: November 2, 2005
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Irinotecan
Cetuximab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014