Phase III Study of Second-Line Treatment for Advanced Pancreatic Cancer: Comparing Chemotherapy and Supportive Care

Sponsor: CONKO-Studiengruppe

Expanded Access
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Sponsor score: 40
Inactive

ClinicalTrials ID:NCT00786058

Provider View

This clinical trial is comparing two treatment options for patients with advanced pancreatic cancer that has not responded to initial treatment with gemcitabine. The study looks at the effects of adding a chemotherapy combination (oxaliplatin, folinic acid, and 5-FU) to supportive care versus supportive care alone.

Patient Parameters

Program Overview

The study aims to find out if adding a chemotherapy combination called OFF (oxaliplatin, folinic acid, and 5-FU) to supportive care can help patients with advanced pancreatic cancer who did not respond to the first treatment with gemcitabine. Supportive care alone is currently the main option for these patients. This trial involves 165 patients who were randomly assigned to receive either the chemotherapy combination plus supportive care or supportive care alone. The chemotherapy is given in cycles, with specific doses on certain days, followed by rest periods.

Description

In this study, researchers are testing whether adding a chemotherapy combination called OFF (oxaliplatin, folinic acid, and 5-FU) to supportive care can improve outcomes for patients with advanced pancreatic cancer that has not responded to the standard treatment with gemcitabine. The study involves 165 patients who were randomly assigned to receive either the chemotherapy combination plus supportive care or supportive care alone.

The chemotherapy is given as an outpatient treatment in cycles. Patients receive 5-FU and folinic acid on days 1, 8, 15, and 22, with oxaliplatin added on days 8 and 22. There is a rest period on days 23 to 42. The study aims to confirm previous findings that this chemotherapy combination can be effective for these patients.

Patients were selected based on their response to the first treatment, their overall health, and the stage of their cancer. The study is conducted across multiple centers to ensure a diverse group of participants.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced pancreatic cancer that has spread and did not respond to initial treatment with gemcitabine.
  • Age over 18 years.
  • Good overall health with a Karnofsky performance status over 70%.
  • Have a tumor that can be measured in two dimensions.
  • Adequate blood cell counts and organ function, including:
    • White blood cell count over 3.5 billion per liter.
    • Platelet count over 100 billion per liter.
    • Kidney function with creatinine clearance over 30 ml/min.
    • Liver enzymes (AST or ALT) less than 2.5 times the upper normal limit, or less than 5 times if there are liver metastases.
  • Pain is under control.

Exclusion Criteria

  • Have any severe medical condition that would interfere with the planned treatment.
  • Have serious heart disease.
  • Have nerve damage greater than grade 2.
  • Have had or currently have another type of cancer.
  • Pregnant or breastfeeding women are not eligible.
  • All participants must provide written informed consent.

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