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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

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


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.

PROJECTED ACCRUAL: A maximum of 44 patients will be accrued for this study within 26 months.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate

Safety Issue:

No

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069413

NCT ID:

NCT00040859

Start Date:

September 2002

Completion Date:

Related Keywords:

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

Name

Location

Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105