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

Gastric Cancer Clinical Trial

Official title:

A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040859
• Other study ID #: NCCTG-N0149
• Secondary ID: NCI-2012-02471CD
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: December 5, 2016
• Start date: September 2002
• Est. completion date: April 2008

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2008
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• capecitabine

• oxaliplatin

Locations

Country	Name	City	State
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	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

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 gast — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate		Up to 3 years	No
Secondary	Time to progression		Up to 3 years	No
Secondary	Overall survival		Up to 3 years	No
Secondary	Quality of life		Up to 3 years	No