Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- dose limiting toxicity (DLT) [ Time Frame: first 21 days ] [ Designated as safety issue: Yes ]
- measurability of lesions, objective status at each evaluation,best response, performance status, CTC response [ Time Frame: course of study ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | March 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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 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 |
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| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anne Schott, MD | The University of Michigan Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Ann Schott, MD, Principal Investigator, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00645333 History of Changes |
| Other Study ID Numbers: | UMCC 2006.119 |
| Study First Received: | March 24, 2008 |
| Last Updated: | November 12, 2012 |
| 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 |
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 May 21, 2013