A Phase 2 interventional study of capecitabine and docetaxel in Esophageal Cancer and Gastric Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
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.
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 46 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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.
Drug: capecitabine · Drug: docetaxel
Proportion of successes
Time frame: Up to 3.5 years
Survival time
Time frame: Up to 3.5 years
Time to disease progression
Time frame: Up to 3.5 years
Duration of response
Time frame: Up to 3.5 years
Time to treatment failure
Time frame: Up to 3.5 years
Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires
Time frame: Up to 3.5 years
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology