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A Phase II Study of Panitumumab in Combination With FOLFIRI After Progression on FOLFIRI Plus Bevacizumab in KRAS(Kirsten Rat Sarcoma) Wild-Type Metastatic Colorectal Cancer.

Phase 2
18 Years
Open (Enrolling)
Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

A Phase II Study of Panitumumab in Combination With FOLFIRI After Progression on FOLFIRI Plus Bevacizumab in KRAS(Kirsten Rat Sarcoma) Wild-Type Metastatic Colorectal Cancer.


I. To determine the median progression-free survival in patients treated with leucovorin
calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and panitumumab for K-ras
wild-type, metastatic colorectal carcinoma who have already progressed on FOLFIRI +


I. To determine the frequency and severity of toxicities of the regimens. II. To determine
overall response rate. III. To determine the median overall survival and the overall
survival rate at 1 year.


Patients receive panitumumab intravenously (IV) over 60-90 minutes, leucovorin calcium IV
over 90 minutes, fluorouracil IV continuously over 46 hours, and irinotecan hydrochloride IV
over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Patients with advanced adenocarcinoma of the colon or rectum not curable with surgery
or radiotherapy and have been previously treated for their disease with FOLFIRI plus
bevacizumab in the first line metastatic setting; patients will only be eligible if
their last line of therapy prior to enrolling onto the study was FOLFIRI and
bevacizumab received no more than 6 months prior to enrolling in this study; they
should have been treated with FOLFIRI plus bevacizumab until disease progression is
radiographically documented

- Patients' tumors will need to tested for the K-RAS mutation status; only those
patients with wild-type or unmutated K-RAS oncogene are eligible to participate in
this study

- Provide written informed consent prior to study-specific screening procedures, with
the understanding that the patient has the right to withdraw from the study at any
time, without prejudice

- Prior cetuximab is allowed in the adjuvant but not in the metastatic setting, but
must have been completed at least 6 months before starting this trial

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1

- Life expectancy greater than 12 weeks

- No active brain metastasis; previously surgically treated or irradiated lesions are
allowed if not clinically active

- Has a negative serum pregnancy test within 7 days prior to registration (female
patients of childbearing potential)

- Ability to understand and willingness to sign a written informed consent

- No history of severe reactions to fluorouracil (5-FU), irinotecan (irinotecan
hydrochloride), or a monoclonal antibody

- Leukocytes >= 3000/uL

- Absolute neutrophil count >= 1500/uL

- Platelets >= 100,000/uL

- Hemoglobin >= 9 mg/dL

- Total bilirubin =< 1.5 X upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 X ULN (or < 5 x
ULN with liver metastases)

- Creatinine clearance (CrCl) >= 30 ml/min (Cockroft-Gault equation)

- Magnesium >= lower limit of normal

- Measurable disease is required according to Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 criteria

- The effects of Panitumumab on the developing human fetus are unknown; for this reason
and because monoclonal antibodies as well as other therapeutic agents used in this
trial are known to be teratogenic, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation and up
to 6 months after completing therapy; should a woman become pregnant or suspect she
is pregnant while participating in this study, she should inform her treating
physician immediately

Exclusion Criteria:

- Pregnant or lactating women; women of childbearing potential with either a positive
or no pregnancy test at baseline; woman or men of childbearing potential not using a
reliable and appropriate contraceptive method; (postmenopausal woman must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential)

- Sexually active males unwilling to practice contraception during the study and 6
months beyond

- Uncontrolled intercurrent illness including but not limited to clinically significant
cardiac disease not well controlled with medication (e.g. congestive heart failure,
symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
within the last 12 months, and serious concurrent infections

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

- KRAS mutant tumors

- Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
(defined as >= Common Toxicity Criteria [CTC] grade 2 [Common Terminology Criteria
for Adverse Events (CTCAE) version 4.0])

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) =< 1 year

- Bevacizumab within the last 4 weeks before starting treatment on trial

- Patient is more than 6 months since the last dose of FOLFIRI

- Patients who have required toxicity related dose reductions of no less than 50% of
the original dose of infusional 5-FU and/or irinotecan during the administration of
FOLFIRI + bevacizumab

- Prior exposure to panitumumab in any setting

- Prior exposure to cetuximab in the metastatic (stage IV) setting

- Radiotherapy =< 14 days prior to enrollment; patients must have recovered from all
radiotherapy-related toxicities

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil, leucovorin (leucovorin calcium), irinotecan, or panitumumab

- Treatment for other carcinomas within the last three years, except cured non-melanoma
skin and treated in-situ cervical cancer

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation

- Major surgery within 4 weeks of the start of study treatment, without complete

- Unwillingness to give written informed consent

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study

- Patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome
(AIDS) and those severely immunocompromised will be excluded; however, no patients
will be tested for HIV

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival(PFS)

Outcome Description:

Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Estimated using the Kaplan-Meier estimator with confidence interval calculated based on the Brookmeyer-Crowley method.

Outcome Time Frame:

Time from study day 1 to the time the patient is first recorded as having disease progression or death, assessed up to 2 years

Safety Issue:


Principal Investigator

Christina Wu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Metastatic colon cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Colorectal Neoplasms



Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240