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

Conditions

• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
  50 mg/sq m IV infusion over 30 min on Days 1 \& 15 of ea cycle
• docetaxel — DRUG
  40 mg/sq m IV infusion over 60 min on Days 1 \& 8 of ea treatment cycle
• gemcitabine hydrochloride — DRUG
  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
• irinotecan hydrochloride — DRUG
  100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 \& 8 of ea cycle

Study Details

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.

Key Dates

Start date

Jan 31, 2001

Status verified

Jul 2016

Primary completion

Jun 30, 2004

Completion

Apr 30, 2009

Study Design

Enrollment

259 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Gemcitabine
  Standard treatment
• Experimental: Gemcitabine + cisplastin
  Addition of cisplastin to gemcitabine
• Experimental: Gemcitabine + docetaxel
  Addition of docetaxel to gemcitabine
• Experimental: Gemcitabine + Irinotecan
  Addition of irinotecan to gemcitabine

Primary Outcome Measure

Overall Survival [ Time Frame: 4 years post treatment ]

Locations (75)

Find similar trials in Anniston, AL

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