NCT00499369|TerminatedPhase 3Results

Study Stopped

Due to inadequate accrual, study was terminated and limited outcome data was reported.

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

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

National Cancer Institute (NCI)ClinicalTrials.gov

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9 other identifiers

NCI-2009-00784CALGB-SWOG-S0600SWOG-S0600CDR0000551934ECOG-SWOG-S0600CAN-NCIC-SWOG-S0600NCCTG-SWOG-S0600S0600U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

382

Timeline

RegisteredJul 2007

StartedJun 2007

CompletionNov 2012

Brief Summary

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jun 2007

Longer than P75 for phase_3

Geographic Reach

1 country

382 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

Study Start

First participant enrolled

June 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

January 15, 2014

Completed

Last Updated

July 31, 2014

Status Verified

March 1, 2014

Enrollment Period

5.4 years

First QC Date

July 10, 2007

Results QC Date

October 22, 2013

Last Update Submit

July 25, 2014

Conditions

Recurrent Colon Cancer Recurrent Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Up to 5 years

Secondary Outcomes (3)

Overall Survival
Up to 5 years
Objective Tumor Response
Up to 5 years
Toxicity
Up to 5 years

Study Arms (3)

Arm I (chemotherapy, cetuximab)

EXPERIMENTAL

Patients receive single-agent irinotecan hydrochloride IV or FOLFIRI IV. They also receive 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.

Drug: irinotecan hydrochlorideDrug: leucovorin calciumDrug: fluorouracilBiological: cetuximab

Arm II (chemotherapy, cetuximab, bevacizumab)

EXPERIMENTAL

Patients receive single-agent irinotecan hydrochloride or FOLFIRI 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.

Drug: irinotecan hydrochlorideDrug: leucovorin calciumDrug: fluorouracilBiological: cetuximabBiological: bevacizumab

Arm III (closed to accrual as of 4/20/2009)

EXPERIMENTAL

Patients receive single-agent irinotecan hydrochloride or FOLFIRI 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.

Drug: irinotecan hydrochlorideDrug: leucovorin calciumDrug: fluorouracilBiological: cetuximabBiological: bevacizumab

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm I (chemotherapy, cetuximab)Arm II (chemotherapy, cetuximab, bevacizumab)Arm III (closed to accrual as of 4/20/2009)

leucovorin calciumDRUG

Given IV

Also known as: CF, CFR, LV

Arm I (chemotherapy, cetuximab)Arm II (chemotherapy, cetuximab, bevacizumab)Arm III (closed to accrual as of 4/20/2009)

fluorouracilDRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Arm I (chemotherapy, cetuximab)Arm II (chemotherapy, cetuximab, bevacizumab)Arm III (closed to accrual as of 4/20/2009)

cetuximabBIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm I (chemotherapy, cetuximab)Arm II (chemotherapy, cetuximab, bevacizumab)Arm III (closed to accrual as of 4/20/2009)

bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm II (chemotherapy, cetuximab, bevacizumab)Arm III (closed to accrual as of 4/20/2009)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 bevacizumab
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 registration
Serum creatinine =\< IULN or measured or estimated creatinine clearance \>= 60 mL/min
+22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead
North Central Cancer Treatment Groupcollaborator
Cancer and Leukemia Group Bcollaborator
Eastern Cooperative Oncology Groupcollaborator
NCIC Clinical Trials Groupcollaborator

Study Sites (382)

Saint Edward Mercy Medical Center

Fort Smith, Arkansas, 72903, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, 94546, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Northbay Cancer Center

Fairfield, California, 94533, United States

Location

Valley Medical Oncology Consultants-Fremont

Fremont, California, 94538, United States

Location

Glendale Memorial Hospital and Health Center

Glendale, California, 91204, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus