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Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00645333
First received: March 24, 2008
Last updated: November 12, 2012
Last verified: November 2012
History of Changes

March 24, 2008
November 12, 2012
March 2008
January 2010   (final data collection date for primary outcome measure)
dose limiting toxicity (DLT) [ Time Frame: first 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00645333 on ClinicalTrials.gov Archive Site
measurability of lesions, objective status at each evaluation,best response, performance status, CTC response [ Time Frame: course of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
Phase I/II Trial of MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer: A Study by the Stem Cell Clinical Consortium

New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur. Recent research suggests that breast tumors have a small number of cells in them that are "breast cancer stem cells", which are very resistant to standard treatment. It is thought that the reason that many patients cannot be cured of their breast cancers is that the stem cells are unable to be killed and remain in the body after standard treatment. Laboratory research has shown that a new drug, MK-0752, can target stem cells and prevent tumor recurrences when the drug is combined with docetaxel, a chemotherapy drug commonly used to treat breast cancer.

We know that MK-0752 is safe when given by itself to people. We do not know if treatment with MK-0752 and docetaxel combined is safe or if it will kill "breast cancer stem cells" in people with breast cancer. This clinical trial is being done to determine the safety of several doses of MK-0752 in combination with docetaxel. Preliminary data about the effectiveness of MK-0752 in combination with docetaxel will be collected. Also, tumor biopsy samples will be taken from some patients who have tumors that can be easily biopsied. The samples will be used to perform research tests to help determine if the "breast cancer stem cells" are being killed by the drug combination.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: MK-0752 and Docetaxel

    Dose Level MK-0752 Docetaxel Peg-filgrastim

    1 300 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 2 450 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 3 600 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 4 800 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9

  • Drug: MK-0752

    Dose Level MK-0752 Docetaxel Peg-filgrastim

    1 300 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 2 450 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 3 600 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9 4 800 mg po daily, days 1-3 80 mg/m2 IV Day 8 6 mg SQ day 9
Experimental: 1
Interventions:
  • Drug: MK-0752 and Docetaxel
  • Drug: MK-0752
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women with metastatic (Stage IV) breast cancer, or with locally advanced breast cancer (Stages IIIA > 10 cm, or Stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy
  • Presence of measurable or evaluable disease
  • Adequate organ function
  • Ability to swallow intact study drug capsules
  • Zubrod Performance Status of 0-1 with at least a 3 month life expectancy
  • Appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity.

Exclusion Criteria:

  • Concurrent treatment with hormonal therapy intended to treat cancer
  • Radiotherapy within 7 days prior to first dose
  • Symptomatic CNS, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks
  • Serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment
  • Patients who are pregnant or nursing
  • Confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645333
UMCC 2006.119
Yes
Ann Schott, MD, University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Anne Schott, MD The University of Michigan Comprehensive Cancer Center
University of Michigan Cancer Center
November 2012

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