NCT00012220

Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.

Detailed description

OBJECTIVES: * Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan. * Compare the time to disease progression in patients treated with these regimens. * Compare the CA 19-9 biomarker response in patients treated with these regimens. * Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the response in patients with measurable disease treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. * Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. * Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	50 mg/sq m IV infusion over 30 min on Days 1 \& 15 of ea cycle
DRUG	docetaxel	40 mg/sq m IV infusion over 60 min on Days 1 \& 8 of ea treatment cycle
DRUG	gemcitabine hydrochloride	Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, \& 15 of ea cycle * cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle * docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 \& 8 of ea cycle
DRUG	irinotecan hydrochloride	100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 \& 8 of ea cycle

Timeline

• Start date: 2001-01-01
• Primary completion: 2004-06-01
• Completion: 2009-04-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

76 sites across 2 countries: United States, Puerto Rico