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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054457 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer |
Drug: capecitabine Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction |
Study Start Date: | September 2003 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.
Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)
Measurable disease*
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for recurrent or metastatic disease except for the following:
Endocrine therapy
Radiotherapy
No prior radiotherapy except for the following:
Surgery
Other
United States, Kansas | |
Associates in Womens Health, PA - North Review | |
Wichita, Kansas, United States, 67203 | |
Cancer Center of Kansas, PA - Kingman | |
Kingman, Kansas, United States, 67068 | |
Cancer Center of Kansas, PA - Wichita | |
Wichita, Kansas, United States, 67214 | |
Cancer Center of Kansas, PA - Chanute | |
Chanute, Kansas, United States, 66720 | |
Cancer Center of Kansas, PA - Dodge City | |
Dodge City, Kansas, United States, 67801 | |
Cancer Center of Kansas, PA - El Dorado | |
El Dorado, Kansas, United States, 67042 | |
Cancer Center of Kansas, PA - Medical Arts Tower | |
Wichita, Kansas, United States, 67208 | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214 | |
Cancer Center of Kansas, PA - Parsons | |
Parsons, Kansas, United States, 67357 | |
Cancer Center of Kansas, PA - Pratt | |
Pratt, Kansas, United States, 67124 | |
Cancer Center of Kansas, PA - Salina | |
Salina, Kansas, United States, 67042 | |
Cancer Center of Kansas, PA - Wellington | |
Wellington, Kansas, United States, 67152 | |
Cancer Center of Kansas, PA - Winfield | |
Winfield, Kansas, United States, 67156 | |
Cancer Center of Kansas, PA - Newton | |
Newton, Kansas, United States, 67114 | |
Southwest Medical Center | |
Liberal, Kansas, United States, 67901 | |
Via Christi Cancer Center at Via Christi Regional Medical Center | |
Wichita, Kansas, United States, 67214 | |
United States, Minnesota | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
Fairview Ridges Hospital | |
Burnsville, Minnesota, United States, 55337 | |
Fairview Southdale Hospital | |
Edina, Minnesota, United States, 55435 | |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | |
Robbinsdale, Minnesota, United States, 55422-2900 | |
Mercy and Unity Cancer Center at Mercy Hospital | |
Coon Rapids, Minnesota, United States, 55433 | |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
Minneapolis, Minnesota, United States, 55407 | |
Minnesota Oncology Hematology, PA - Maplewood | |
Maplewood, Minnesota, United States, 55109 | |
Minnesota Oncology Hematology, PA - Woodbury | |
Woodbury, Minnesota, United States, 55125 | |
Park Nicollet Cancer Center | |
St. Louis Park, Minnesota, United States, 55416 | |
Ridgeview Medical Center | |
Waconia, Minnesota, United States, 55387 | |
United Hospital | |
St. Paul, Minnesota, United States, 55102 | |
Mercy and Unity Cancer Center at Unity Hospital | |
Fridley, Minnesota, United States, 55432 |
Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000270681, NCCTG-N0242 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054457 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the stomach adenocarcinoma of the esophagus stage IV gastric cancer |
recurrent gastric cancer stage IV esophageal cancer recurrent esophageal cancer |
Capecitabine Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Stomach cancer Recurrence Carcinoma Docetaxel Stomach Diseases |
Digestive System Diseases Stomach Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |