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A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors

Phase 2
18 Years
Open (Enrolling)
Cancer, Colon Cancer, Colorectal Cancer, Metastatic Cancer, Rectal Cancer, Metastatic Colorectal Cancer

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Trial Information

A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors

Inclusion Criteria

Inclusion Criteria

- Diagnosis of metastatic adenocarcinoma of the colon or rectum that cannot, in the
opinion of the investigator, be cured by surgical resection at the time of

- Wild-type KRAS expressing mCRC from the primary tumor or metastasis.

- Failure of prior first-line oxaliplatin-based chemotherapy with bevacizumab (at least
four therapeutic doses of oxaliplatin-based chemotherapy and bevacizumab) for mCRC.

- At least one uni-dimensionally measurable lesion per modified RECIST criteria.

- Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Man or woman 18 years of age or older

- Hematology, chemistry, coagution, metabolic functions within normal or
protocol-defined limits

Exclusion Criteria

- Previous irinotecan, anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib,
gefitinib, lapatinib) or vaccine for the treatment of mCRC

- Radiotherapy ≤ 14 days before randomization

- Evidence of central nervous system (CNS) metastases

- Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the
investigator, precludes subject from participation

- History of other invasive primary cancer, except:

- Curatively resected or treated non-melanomatous skin cancer

- Curatively treated cervical carcinoma in situ

- Other primary solid tumor treated curatively and no treatment administered ≤ 2 years
before randomization and, in the investigator's opinion, it is unlikely that there
will be a recurrence ≤ 2 years post randomization


- C hronic daily treatment (as determined by the investigator) with aspirin (> 325
mg/day) or non steroidal anti inflammatory agents known to inhibit platelet function

- Infection requiring a course of systemic anti-infectives that was completed ≤ 14 days
before randomization (exception can be made at the judgment of the investigator for
oral treatment of an uncomplicated urinary tract infection [UTI])

- Subjects concurrently receiving any investigational agent or therapy ≤ 30 days before


- Significant cardiovascular risk as defined by the protocol

- History of peripheral arterial ischemia ≤ 24 weeks before randomization (subjects
with brief, reversible, exercise-induced claudication are eligible)

- History of visceral arterial ischemia ≤ 24 weeks before randomization

- Significant bleeding risk:

- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days
before randomization

- Anticipation of need for major surgical procedures during the course of the study

- C ore biopsy or other minor procedure, excluding placement of a vascular access
device ≤ 7 days before randomization

- A ny significant bleeding that is not related to the primary colon tumor ≤ 24 weeks
before randomization

- P re-existing bleeding diathesis or coagulopathy with the exception of
well-controlled chronic anticoagulation therapy

- Serious or non-healing wounds, skin ulcers, or unhealed bone fractures

- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled
gastrointestinal ulcer ≤ 28 days before randomization

- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest x-ray (CXR) or computed
tomography (CT) scan

- Clinically significant ascites

- Subjects known to be human immunodeficiency virus (HIV) positive or known to have
chronic or active hepatitis B or C infection

- Men and women of childbearing potential (women who are post-menopausal < 52 weeks,
not surgically sterilized, or not abstinent) who do not consent to use adequate
contraception (according to institutional standard of care) during the course of the
study and after the last date of receiving second-line treatment (24 weeks for women,
4 weeks for men)

- Women who test positive for serum or urine pregnancy test ≤ 72 hours before
randomization or are breast-feeding

- Subjects allergic to any component that is part of the treatment regimen

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Participants are followed until death or 78 weeks after the last randomized participant.

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

August 2012

Related Keywords:

  • Cancer
  • Colon Cancer
  • Colorectal Cancer
  • Metastatic Cancer
  • Rectal Cancer
  • Metastatic Colorectal Cancer
  • EGFR
  • 2nd Line Therapy
  • 2nd Line mCRC Therapy
  • mCRC
  • Irinotecan
  • panitumumab
  • bevacizumab
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary