A Phase 2 interventional study of bortezomib and carboplatin in Esophageal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed. 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: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable, metastatic cancer of the esophagus or gastroesophageal junction.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17 months.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 37 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal 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:
Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites:
Gastric cardia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
Drug: bortezomib · Drug: carboplatin · Drug: paclitaxel
Confirmed tumor response rate
Time frame: Up to 3 years
Time to tumor progression
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
No study locations are listed for this record.
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