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Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) As Second-Line Therapy for Patients With Metastatic Colorectal Cancer Who Have Progressed on Bevacizumab With Either FOLFOX, OPTIMOX or XELOX

Phase 3
18 Years
Open (Enrolling)
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

Thank you

Trial Information

Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) As Second-Line Therapy for Patients With Metastatic Colorectal Cancer Who Have Progressed on Bevacizumab With Either FOLFOX, OPTIMOX or XELOX


I. Compare progression-free survival of patients with metastatic colorectal cancer that
progressed on first-line therapy comprising bevacizumab and FOLFOX, OPTIMOX, or XELOX
treated with irinotecan hydrochloride-based chemotherapy and cetuximab with vs without

II. Compare overall survival of patients treated with these regimens. III. Compare objective
tumor response (confirmed and unconfirmed, complete and partial response) in patients with
measurable disease treated with these regimens.

IV. Compare the tolerability and safety profile of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
Zubrod performance status (0 vs 1 or 2), discontinuation of oxaliplatin during first-line
therapy (yes vs no), planned concurrent chemotherapy (FOLFIRI vs single-agent irinotecan
hydrochloride), and time from last dose of bevacizumab (14-42 days vs >= 43 days).

All patients receive 1 of the following chemotherapy regimens:

SINGLE AGENT IRINOTECAN HYDROCHLORIDE: Patients receive irinotecan hydrochloride
intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.

FOLFIRI: Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium
IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours on days 1 and 2.
Treatment repeats every 14 days in the absence of disease progression or unacceptable

Patients are then randomized to 1 of 3 treatment arms.

ARM I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above
and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon
chemotherapy regimen) in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above
and cetuximab as in arm I. Patients also receive bevacizumab IV over 30 minutes on day 1.
Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of
disease progression or unacceptable toxicity.

ARM III (closed to accrual as of 4/20/2009): Patients receive single-agent irinotecan
hydrochloride or FOLFIRI as outlined above and cetuximab as in arm I. Patients also receive
a higher dose of bevacizumab (higher than in arm II) IV over 30 minutes on day 1. Courses
repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 2 years and
then once a year for 3 years.

Inclusion Criteria:

- Patients must have metastatic colorectal cancer that has been histologically or
cytologically confirmed; confirmation may be from either the primary tumor or a
metastasis; patients must have wild type KRAS

- Patients must be registered within 28 days of documented disease progression on first
line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this
progression must have occurred within 90 days after the last dose of bevacizumab;
patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and
bevacizumab and then had subsequent progression while on fluoropyrimidine and
bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events
in the first-line setting are not eligible

- Measurable or nonmeasurable disease

- At least 14 days must have elapsed since the last dose of first line chemotherapy and

- Patients must not have received prior treatment with irinotecan (either as adjuvant
or metastatic treatment)

- Patients must have no history of prior treatment with cetuximab or other agents
targeting VEGF or EGFR (except for bevacizumab)

- Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last
treatment; all adverse events related to radiation therapy must be resolved

- Prior surgery is allowed, provided at least 28 days have elapsed since any major
surgery and patient has recovered from all effects

- Zubrod performance status 0-2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 9 g/dL

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

- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate
transaminase (SGPT) =< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT
must be =< 5 x IULN; these results must be obtained within 28 days prior to

- Serum creatinine =< IULN or measured or estimated creatinine clearance >= 60 mL/min

- Patients must not have a history or known presence of brain metastasis

- Patients may be on full dose anticoagulation with warfarin provided that the patient
has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained
within 28 days prior to registration

- No clinically relevant bleeding diathesis or coagulopathy

- Patients must not have experienced nephrotic range proteinuria from prior bevacizumab
therapy; urine protein must be screened by urine analysis for Urine Protein
Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained
and the level must be < 1,000 mg for patient enrollment; urine protein and creatinine
used in calculating the UPC ratio must be obtained within 28 days prior to

- No uncontrolled high blood pressure (BP) (i.e., systolic BP > 150 mm Hg and
diastolic BP > 90 mm Hg)

- No cardiovascular event within the past 6 months, including any of the following:

- Arterial thrombosis

- Unstable angina

- Myocardial infarction

- Cerebrovascular accident

- Patients must not have New York Heart Association (NYHA) >= Grade 2 congestive heart

- Patients must not have unstable symptomatic arrhythmia requiring medication;
(patients with chronic, controlled arrhythmias such as atrial fibrillation or
paroxysmal supraventricular tachycardia [PSVT] are eligible)

- No clinically significant peripheral vascular disease

- No serious or nonhealing active wound, ulcer, or bone fracture

- No history of gastrointestinal (GI) perforation while on prior bevacizumab

- No significant bleeding episodes (e.g., hemoptysis or upper or lower GI bleeding)
within the past 6 months unless the source of bleeding has been resected

- No known hypersensitivity to bevacizumab or known potential hypersensitivity to

- No other concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or
any other type of anticancer treatment

- Due to the possibility of harm to a fetus or nursing infant from this treatment
regimen, patients must not be pregnant or nursing; women and men of reproductive
potential must have agreed to use an effective contraceptive method

- No other malignancy within the past 5 years except for adequately treated basal or
squamous cell skin cancer or cervical cancer in situ

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- At the time of patient registration, the treating institution's name and
identification (ID) number must be provided to the Data Operations Center in Seattle
in order to ensure that the current (within 365 days) date of institutional review
board approval for this study has been entered into the data base

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

Outcome Description:

Evaluated by the stratified log-rank test.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Philip Gold

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



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Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
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Marietta Memorial Hospital Marietta, Ohio  45750
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Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Saint Ann's Hospital Westerville, Ohio  43081
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The Don and Sybil Harrington Cancer Center Amarillo, Texas  79106
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Saint Vincent Hospital Green Bay, Wisconsin  54301
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Harbin Clinic Medical Oncology and Clinical Research Rome, Georgia  30165
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Cancer Center of Kansas-Liberal Liberal, Kansas  67901
Memorial Hospital at Easton - Shore Regional Cancer Center Easton, Maryland  21601
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
University of Missouri - Ellis Fischel Columbia, Missouri  65203
Veterans Administration Columbia, Missouri  65201
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Cancer Centers of the Carolinas - Faris Greenville, South Carolina  29605
Cancer Centers of the Carolinas-Greer Radiation Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas-Greer Medical Oncology Greer, South Carolina  29650
Skagit Valley Hospital Mt. Vernon, Washington  98273
Evergreen Hematology and Oncology PS Spokane, Washington  99218
West Virginia University Charleston Charleston, West Virginia  25304
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Medical Consultants Limited Milwaukee, Wisconsin  53215
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst, North Carolina  28374
Palchak David MD Pismo Beach, California  93449
Doctors Carrol, Sheth, Raghavan Louisville, Kentucky  40215
University of Tennessee - Memphis Memphis, Tennessee  38163
United General Hospital Sedro-Woolley, Washington  98284
Columbia Saint Mary's Water Tower Medical Commons Milwaukee, Wisconsin  53211
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Space Coast Cancer Centers-Titusville Titusville, Florida  32796
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Via Christi Hospital-Pittsburg Pittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Springfield Regional Medical Center Springfield, Ohio  45505
Promise Regional Medical Center-Hutchinson Hutchinson, Kansas  65702
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Self Regional Healthcare Greenwood, South Carolina  29646
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
Aurora Cancer Care-Southern Lakes Elkhorn, Wisconsin  53121
South Carolina Oncology Associates PA Columbia, South Carolina  29210