Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sylvester Cancer Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00290693 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with recurrent or progressive metastatic pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: capecitabine Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Multicenter Phase II Study of Capecitabine and Docetaxel for Previously Treated Pancreatic Cancer Patients "CapTere" |
Estimated Enrollment: | 45 |
Study Start Date: | June 2004 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14 and docetaxel IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically documented adenocarcinoma of the pancreas
Metastatic disease
Measurable tumor, defined as any lesion ≥ 1 cm by spiral CT scan or ≥ 2 cm by conventional methods
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | |
Miami, Florida, United States, 33136 |
Study Chair: | Caio Max S. Rocha Lima, MD | Sylvester Cancer Center |
Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center - Miami ( Caio Max S. Rocha Lima ) |
Study ID Numbers: | CDR0000456363, SCCC-2003099, SCCC-2003/0652C, AVENTIS-14056, WIRB-20051007, FWA00002247 |
Study First Received: | February 9, 2006 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00290693 History of Changes |
Health Authority: | United States: Federal Government |
recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence |
Docetaxel Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |