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Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IV gastric cancer, recurrent gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists Unresectable disease Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach Measurable disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 3 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Other: Able to swallow capecitabine No unresolved gastrointestinal bleeding No uncontrolled infection No chronic debilitating disease No peripheral neuropathy grade 2 or greater No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biological therapy for recurrent or metastatic disease No concurrent biologic agents Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy No prior radiotherapy for recurrent or metastatic disease No prior radiotherapy to more than 25% of the bone marrow Prior adjuvant or neoadjuvant radiotherapy allowed More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: More than 4 weeks since prior abdominal exploration with surgical resection More than 3 weeks since prior abdominal exploration without surgical resection Other: No concurrent oral cryotherapy during oxaliplatin administration

Sites / Locations

  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Avera Cancer Institute
  • Medical X-Ray Center, PC
  • Sanford Cancer Center at Sanford USD Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

oxaliplatin + capecitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective tumor response rate

Secondary Outcome Measures

Time to progression
Overall survival
Quality of life

Full Information

First Posted
July 8, 2002
Last Updated
December 5, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00040859
Brief Title
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Official Title
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
stage IV gastric cancer, recurrent gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxaliplatin + capecitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Objective tumor response rate
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
Up to 3 years
Title
Overall survival
Time Frame
Up to 3 years
Title
Quality of life
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists Unresectable disease Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach Measurable disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 3 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Other: Able to swallow capecitabine No unresolved gastrointestinal bleeding No uncontrolled infection No chronic debilitating disease No peripheral neuropathy grade 2 or greater No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biological therapy for recurrent or metastatic disease No concurrent biologic agents Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy No prior radiotherapy for recurrent or metastatic disease No prior radiotherapy to more than 25% of the bone marrow Prior adjuvant or neoadjuvant radiotherapy allowed More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: More than 4 weeks since prior abdominal exploration with surgical resection More than 3 weeks since prior abdominal exploration without surgical resection Other: No concurrent oral cryotherapy during oxaliplatin administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminah Jatoi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20126980
Citation
Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.
Results Reference
background
PubMed Identifier
16303863
Citation
Jatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, Fitch TR, Rowland KM Jr; North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Jan;17(1):29-34. doi: 10.1093/annonc/mdj063. Epub 2005 Nov 22.
Results Reference
result

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Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

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