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

NCT ID: NCT00040859

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oxaliplatin + capecitabine

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.

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Interventions

capecitabine

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Medical X-Ray Center, PC

Sioux Falls, South Dakota, United States

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20126980 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16303863 (View on PubMed)

Other Identifiers

NCI-2012-02471

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000069413

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N0149

Identifier Type: -

Identifier Source: org_study_id