A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Capecitabine; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02565641

ML16832

Details and patient eligibility

About

This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants 18 to 75 years of age
• Locally advanced or metastatic pancreatic cancer

Exclusion criteria

• Prior chemotherapy for pancreatic cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Capecitabine + Gemcitabine

Experimental group

Description:

Participants will receive oral capecitabine (830 milligrams per meter-squared \[mg/m\^2\]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks \[q4w\]) along with IV infusion of gemcitabine (1000 mg/m\^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).

Treatment:

Drug: Capecitabine

Drug: Gemcitabine