Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040859
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-07-08
Brief Title:
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus Gastroesophageal Junction and Gastric Cardia
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer
PURPOSE Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia treated with oxaliplatin and capecitabine
Secondary
Determine the time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive 2 additional courses after CR
Quality of life is assessed at baseline and then every 3 weeks prior to each course of chemotherapy
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
Primary
Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus gastroesophageal junction or gastric cardia treated with oxaliplatin and capecitabine
Secondary
Determine the time to progression and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive 2 additional courses after CR
Quality of life is assessed at baseline and then every 3 weeks prior to each course of chemotherapy
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069413 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02471 | REGISTRY | None | None |