Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

NCT00042939 | Completed Phase 2 Results

• 3 other identifiers: CDR0000069486U10CA021115E8200 [ECOG]
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; metastatic pancreatic cancer; EGF-r; irinotecan; docetaxel; cetuximab

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)

  Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

  Assessed every 12 weeks until progression

Secondary Outcomes (4)

• Progression-free Survival

  Assessed every 3 months for 2 years and then every 6 months for 1 year

• Overall Survival

  Assessed every 3 months for 2 years and then every 6 months for 1 year

• Epidermal Growth Factor Receptor (EGFR) Status

  Original tumor tissue samples submitted within one month of patient randomization

• Proportion of Patients With Thromboembolic Events

  Assessed every 6 weeks while on treatment and for 30 days after the end of treatment

Study Arms (2)

Irinotecan/Docetaxel

ACTIVE COMPARATOR

Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles.

Drug: docetaxel; Drug: irinotecan hydrochloride

Irinotecan/Docetaxel/Cetuximab

EXPERIMENTAL

Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks.

Biological: cetuximab; Drug: docetaxel; Drug: irinotecan hydrochloride

Interventions

cetuximab BIOLOGICAL

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

Also known as: Erbitux, C225

Irinotecan/Docetaxel/Cetuximab

docetaxel DRUG

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.

Also known as: Taxotere

Irinotecan/Docetaxel; Irinotecan/Docetaxel/Cetuximab

irinotecan hydrochloride DRUG

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.

Also known as: Camptosar

Irinotecan/Docetaxel; Irinotecan/Docetaxel/Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (2)

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Docetaxel; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG Statistical Office

617-632-3012

Study Officials

• Barbara A. Burtness, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: December 9, 2003
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 6, 2023
• Results First Posted: July 19, 2011

Record last verified: 2023-06