Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00042939

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

Condition	Intervention	Phase
Pancreatic Cancer	Biological: cetuximab Drug: docetaxel 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:	Phase II Trial of Irinotecan/Docetaxel for Advanced Pancreatic Cancer, With Randomization Between Irinotecan/Docetaxel and Irinotecan/Docetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor (EGF-r)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Irinotecan U 101440E Docetaxel Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:

Response Rate by RECIST [ Time Frame: Assessed every 12 weeks until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free Survival [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Assessed every 3 months for 2 years and then every 6 months for 1 year ] [ Designated as safety issue: No ]
Epidermal Growth Factor Receptor (EGFR) Status [ Time Frame: Original tumor tissue samples submitted within one month of patient randomization ] [ Designated as safety issue: No ]
Rate of Thromboembolic Events [ Time Frame: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	94
Study Start Date:	July 2003
Study Completion Date:	August 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Irinotecan/Docetaxel	Drug: docetaxel Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution. Other Name: Taxotere Drug: irinotecan hydrochloride After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Other Name: Camptosar
Experimental: Irinotecan/Docetaxel/Cetuximab	Biological: cetuximab Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks. Other Names: Erbitux C225 Drug: docetaxel Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution. Other Name: Taxotere Drug: irinotecan hydrochloride After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Other Name: Camptosar

Arms

Assigned Interventions

Active Comparator: Irinotecan/Docetaxel

Drug: docetaxel

Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.

Other Name: Taxotere

Drug: irinotecan hydrochloride

After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.

Other Name: Camptosar

Experimental: Irinotecan/Docetaxel/Cetuximab

Biological: cetuximab

Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks.

Other Names:

Erbitux
C225

Drug: docetaxel

Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution.

Other Name: Taxotere

Drug: irinotecan hydrochloride

After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.

Other Name: Camptosar

Detailed Description:

OBJECTIVES:

Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas.
Determine the time to progression and overall survival of patients treated with these regimens.
Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22.
Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36.

Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed metastatic adenocarcinoma of the pancreas
Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing
At least 1 unidimensionally measurable primary or metastatic lesionge
Age of 18 and over
ECOG performance status 0-1
Negative pregnancy test
Fertile patients must use effective contraception
Creatinine clearance > 60 mL/min
LVEF normal
Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Bilirubin ≤ upper limit of normal (ULN)*
SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following*:
- SGOT or SGPT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
- SGOT or SGPT ≤ 1.5 times ULN AND alkaline phosphatase > ULN but ≤ 2.5 times ULN
- SGOT or SGPT ≤ ULN AND alkaline phosphatase > 2.5 but ≤ 4 times ULN

NOTE: *Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests

Exclusion Criteria:

History of uncontrolled arrhythmias
History of congestive heart failure
History of uncontrolled angina pectoris
Prior chemotherapy
Pre-existing neuropathy ≥ grade 2
Prior hypersensitivity to polysorbate 80
Pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042939

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara A. Burtness, MD

Fox Chase Cancer Center

More Information

Additional Information:

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

Publications:

Burtness BA, Powell ME, Berlin JD, et al.: Phase II ECOG trial of irinotecan/docetaxel with or without cetuximab in metastatic pancreatic cancer: updated survival and CA19-9 results. [Abstract] J Clin Oncol 26 (Suppl 15): A-4642, 2008.

Burtness BA, Powell M, Berlin J, et al.: Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. [Abstract] J Clin Oncol 25 (Suppl 18): A-4519, 2007.

Responsible Party:	Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00042939 History of Changes
Other Study ID Numbers:	CDR0000069486, U10CA021115, E8200 [ECOG]
Study First Received:	August 5, 2002
Results First Received:	June 21, 2011
Last Updated:	June 21, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:

pancreatic cancer
metastatic pancreatic cancer
EGF-r

irinotecan
docetaxel
cetuximab

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Irinotecan
Camptothecin
Docetaxel

Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012