Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00678626
First received: May 12, 2008
Last updated: December 3, 2008
Last verified: November 2008
  Purpose

This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.


Condition Intervention Phase
Breast Cancer
Drug: CP-751,871
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of CP-751,871 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Optional tissue markers of the IGF-1R pathway from tumor tissue obtained [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
combination of CP-751,871 + docetaxel administered
Drug: CP-751,871
Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
Active Comparator: Arm B
chemotherapy
Drug: Docetaxel
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.

  Eligibility

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

Inclusion Criteria:

  • histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
  • Her-2negative breast cancer or unknown Her-2 status.
  • at least 1 measurable lesion as defined by RECIST.
  • ECOG status 0-1
  • adequate bone marrow, hepatic and renal function.
  • left ventricular ejection fraction of greater than or equal to 50%.
  • willingness to discontinue hormonal therapy.

Exclusion Criteria:

  • any previous chemotherapy for advanced disease.
  • prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
  • symptomatic brain metastases.
  • prior anti-IGF-1R based investigational therapy.
  • peripheral neuropathy greater than grade 2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678626

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00678626     History of Changes
Other Study ID Numbers: A4021008
Study First Received: May 12, 2008
Last Updated: December 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014