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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: oxaliplatin; Drug: capecitabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00040859

CDR0000069413 (Registry Identifier)

NCI-2012-02471 (Registry Identifier)

NCCTG-N0149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

oxaliplatin + capecitabine

Experimental group

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.

Treatment:

Drug: capecitabine

Drug: oxaliplatin