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Old 04-16-2009, 05:46 PM   #1
Rich66
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Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Ca

Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, August 2008
First Received: March 24, 2008 Last Updated: August 8, 2008 History of Changes
Sponsored by: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center ClinicalTrials.gov Identifier: NCT00645333
Purpose 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.


Condition Intervention Phase Metastatic Breast Cancer
Drug: MK-0752 and Docetaxel
Drug: MK-0752
Phase I
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Study Type: Interventional Study Design: Treatment, Open Label, Single Group Assignment Official Title: 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
Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • dose limiting toxicity (DLT) [ Time Frame: first 21 days ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:
  • measurability of lesions, objective status at each evaluation,best response, performance status, CTC response [ Time Frame: course of study ] [ Designated as safety issue: No ]


Estimated Enrollment: 30 Study Start Date: February 2008 Estimated Study Completion Date: March 2012 Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions 1: Experimental 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





Eligibility

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



Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645333

Contacts
Contact: Cancer Answer Line 1 800 865-1125 canceranswerline@umich.edu Contact: Judith Luckhardt, R.N. 734 647-5345 jluck@umich.edu

Locations

United States, Massachusetts Dana Farber Cancer Institute Recruiting Boston, Massachusetts, United States, 02115 Contact: Ian Krop, M.D., Ph.D. 616-632-5958 ikrop@partners.org Contact: Jason Russak 617 632-4915 jason_russak@dfci.harvard.edu

United States, Michigan University of Michigan Cancer Center Recruiting Ann Arbor, Michigan, United States, 48109 Contact: Cancer Answer Line 800-865-1125 canceranswetline@umich.edu Contact: Judith Luckhardt, RN 734 647-5345 jluck@umich.edu

Principal Investigator: Anne F Schott, M.D. United States, Texas Baylor College of Medicine Recruiting Houston, Texas, United States, 77030 Contact: Jenny Chang, M.D. 713-798-1905 jcchang@bcm.tmc.edu Contact: Anne Pavlick, CRC ll 713 798-1975 acpavlic@bcm.tmc.edu Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Anne Schott, MD The University of Michigan Comprehensive Cancer Center

More Information
No publications provided

Responsible Party: University of Michigan ( Anne F. Schott, M.D. ) Study ID Numbers: UMCC 2006.119 Study First Received: March 24, 2008 Last Updated: August 8, 2008 ClinicalTrials.gov Identifier: NCT00645333 History of Changes Health Authority: United States: Food and Drug Administration
Keywords provided by University of Michigan Cancer Center: Women or men with locally advanced or metastatic breast cancer that did not respond to first-line anthracycline-based therapy
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Old 10-18-2009, 01:42 PM   #2
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Re: Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breas

Anyone near these locations looking into this?
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Old 12-13-2009, 05:01 PM   #3
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Re: Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breas

Trial finished, results announced at SABC 2009: http://her2support.org/vbulletin/sho...009#post213906
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Mom's treatment history (link)
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