Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Adult Solid Neoplasm, Inflammatory Breast Carcinoma, Male Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
In brief
Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastatic solid tumors or stage IIIA or stage IIIB breast cancer. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor cells.
Key facts
- Study ID
- NCT00070252
- Run by
- National Cancer Institute (NCI)
- People needed
- 53
- Starts
- 2003-09-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2015-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed solid tumor
- Locally advanced or metastatic
- No known standard therapy that is potentially curative or definitely capable of extending life expectancy
- No history of metastatic brain disease within the past 6 months
- Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication
- Histologically confirmed breast cancer
- Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis
- Invasive disease confirmed by 1 of the following*:
- Incisional biopsy
- Punch biopsy (applicable for clinical T4b tumors)
- Core needle (cutting needle) biopsies
- No distant metastatic disease
- Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-1
- Absolute neutrophil count at least 2,000/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 10.0 g/dL
- Bilirubin no greater than upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance at least 50 mL/min
- No cardiac arrhythmia
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- Howard University Cancer Center CCOP — Washington D.C., District of Columbia, United States
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Wisconsin Medical School — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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