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

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

• Registration Number: NCT00012220
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2001-03-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-06
• Study Completion: 2009-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine + cisplastin	gemcitabine hydrochloride	Addition of cisplastin to gemcitabine
Gemcitabine + docetaxel	gemcitabine hydrochloride	Addition of docetaxel to gemcitabine
Gemcitabine + Irinotecan	gemcitabine hydrochloride	Addition of irinotecan to gemcitabine
Gemcitabine	gemcitabine hydrochloride	Standard treatment
Gemcitabine + Irinotecan	irinotecan hydrochloride	Addition of irinotecan to gemcitabine
Gemcitabine + cisplastin	cisplatin	Addition of cisplastin to gemcitabine
Gemcitabine + docetaxel	docetaxel	Addition of docetaxel to gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall Survival	4 years post treatment

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	treatment up to 4 years post treatment
Toxicity	treatment and up to 4 years post treatment

Trial Locations

Locations (76)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Veterans Affairs Medical Center - Washington, DC; 🇺🇸 Washington, District of Columbia, United States

Broward General Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

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