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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00012220

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Cisplatin Gemcitabine Irinotecan U 101440E Docetaxel Gemcitabine hydrochloride Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Overall Survival [ Time Frame: 4 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disease progression [ Time Frame: treatment up to 4 years post treatment ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: treatment and up to 4 years post treatment ] [ Designated as safety issue: Yes ]

Enrollment:	259
Study Start Date:	January 2001
Study Completion Date:	April 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gemcitabine Standard treatment	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
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 IV infusion over 30 min Days 1 & 8 of ea cycle
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 IV infusion over 30 min Days 1 & 8 of ea cycle
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 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the pancreas
Metastatic disease by CT scan

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

CTC 0-2

Life expectancy:

Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

Creatinine no greater than 1.5 mg/dL

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

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

Endocrine therapy:

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

Radiotherapy:

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

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012220

Show 76 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Matthew Kulke, MD

Dana-Farber Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 Oct 26; [Epub ahead of print]

Kulke MH, Niedzwiecki D, Tempero MA, et al.: A randomized phase II study of gemcitabine/cisplatin, gemcitabine fixed dose rate infusion, gemcitabine/docetaxel, or gemcitabine/irinotecan in patients with metastatic pancreatic cancer (CALGB 89904). [Abstract] J Clin Oncol 22 (Suppl 14): A-4011, 316s, 2004.

Responsible Party:	Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00012220 History of Changes
Other Study ID Numbers:	CDR0000068495, U10CA031946, CALGB-89904
Study First Received:	March 3, 2001
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:

adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Irinotecan
Docetaxel
Cisplatin
Camptothecin
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012