Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• panitumumab — BIOLOGICAL
  Given intravenously 6mg/kg every 2 weeks
• erlotinib hydrochloride — DRUG
  Given orally 150mg daily
• irinotecan hydrochloride — DRUG
  Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Study Details

RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.

Key Dates

Start date

Jan 18, 2010

Status verified

Apr 2019

Primary completion

Jan 31, 2015

Completion

Jan 31, 2015

Study Design

Enrollment

28 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Erlotinib + Panitumumab + Irinotecan
  Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B: Erlotinib + Panitumumab
  Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.
• Experimental: Arm C: Erlotinib + Panitumumab
  Patients receive erlotinib hydrochloride and panitumumab as in arm B.

Primary Outcome Measure

Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) [ Time Frame: At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks. ]

Locations (10)

Find similar trials in Arlington Heights, IL

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