Gemcitabine Alone Or In Combination With Other Chemotherapy Drugs In Treating Patients With Metastatic Cancer Of The Pancreas

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: cisplatin
DRUG: docetaxel
DRUG: gemcitabine hydrochloride
DRUG: irinotecan hydrochloride

CALGB-89904
U10CA031946 (U.S. NIH Grant/Contract)
CDR0000068495 (REGISTRY Identifier) (REGISTRY: NCI Physician Data Query)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-03-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-07-12
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-07-14
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2016-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Gemcitabine Standard treatment	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 I DRUG: irinotecan hydrochloride 100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle
EXPERIMENTAL: Gemcitabine + cisplastin Addition of cisplastin to gemcitabine	DRUG: cisplatin 50 mg/sq m IV infusion over 30 min on Days 1 & 15 of ea 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 I
EXPERIMENTAL: Gemcitabine + docetaxel Addition of docetaxel to gemcitabine	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 I
EXPERIMENTAL: Gemcitabine + Irinotecan Addition of irinotecan to gemcitabine	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 I DRUG: irinotecan hydrochloride 100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 & 8 of ea cycle

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		4 years post treatment

Secondary Outcome Measures	Measure Description	Time Frame
Time to disease progression		treatment up to 4 years post treatment
Toxicity		treatment and up to 4 years post treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed adenocarcinoma of the pancreas
Metastatic disease by CT scan

18 and over

CTC 0-2

Not specified

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 2.5 times upper limit of normal (ULN)
Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
Alkaline phosphatase any value if SGOT less than 1.5 times ULN

Creatinine no greater than 1.5 mg/dL

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study
No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

No prior chemotherapy except fluorouracil (5-FU)
At least 2 weeks since prior 5-FU
No other concurrent chemotherapy

No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic

At least 2 weeks since prior radiotherapy
No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Matthew Kulke, MD, Dana-Farber Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kulke MH, Tempero MA, Niedzwiecki D, Hollis DR, Kindler HL, Cusnir M, Enzinger PC, Gorsch SM, Goldberg RM, Mayer RJ. Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904. J Clin Oncol. 2009 Nov 20;27(33):5506-12. doi: 10.1200/JCO.2009.22.1309. Epub 2009 Oct 26.

Learn

Resources

Patients

Caregivers

Clinical Trial Record