Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Capecitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00585078

OX-03-033 (Other Identifier)

03-398

Details and patient eligibility

About

There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Full description

OBJECTIVES:

Primary

• To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
• To determine safety
• To determine overall survival
• To determine time to progression

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• At least one measurable lesion according to RECIST criteria that has not been irradiated
• Adequate laboratory parameters as outlined in protocol
• Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
• Negative serum pregnancy test within 14 days prior to registration

Exclusion criteria

• Pregnant or lactating women
• Life expectancy < 3 months
• Serious, uncontrolled, concurrent infection(s)
• Any prior oxaliplatin or fluoropyrimidine therapy
• More than one prior chemotherapy regimen for unresectable or metastatic disease
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
• Any active second malignancy
• Clinically significant cardiac disease or myocardial infarction within the last 12 months
• Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
• Other serious uncontrolled medical conditions
• Major surgery within 4 weeks of the start of study treatment, without complete recovery
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Known, existing uncontrolled coagulopathy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

CAPOX

Experimental group

Description:

Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine