NCT00321685|CompletedPhase 2ResultsDMC

Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer

Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2009-01081CDR0000471148ECOG-E3204E3204U10CA180820U10CA021115

Study Type

interventional

Target

Locations

1 country

Sites

107

Timeline

RegisteredMay 2006

StartedJul 2006

CompletionFeb 2019

Brief Summary

This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jul 2006

Longer than P75 for phase_2

Geographic Reach

1 country

107 active sites

Status

completed

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

12.6 years study duration

First Submitted

Initial submission to the registry

May 2, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed

3 months until next milestone

Study Start

First participant enrolled

July 25, 2006

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2013

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed

Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

7.1 years

First QC Date

May 2, 2006

Results QC Date

April 21, 2015

Last Update Submit

March 13, 2019

Conditions

Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v7 Stage III Rectal Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Pathologic Complete Response Rate
Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients
Assessed at surgery time

Secondary Outcomes (4)

Resection Rate for T3 Rectal Cancers
Assessed at surgery time
Resection Rate for T4 Rectal Cancers
Assessed at surgery time
5-year Overall Survival Rate
survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
5-year Recurrence-free Survival Rate
recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration

Study Arms (1)

Treatment (bevacizumab and chemoradiotherapy)

EXPERIMENTAL

See Detailed Description

Biological: BevacizumabDrug: CapecitabineDrug: FluorouracilDrug: Leucovorin CalciumDrug: OxaliplatinRadiation: Radiation TherapyProcedure: Therapeutic Conventional Surgery

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF

Treatment (bevacizumab and chemoradiotherapy)

CapecitabineDRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (bevacizumab and chemoradiotherapy)

FluorouracilDRUG

Given IV

Also known as: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Treatment (bevacizumab and chemoradiotherapy)

Leucovorin CalciumDRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, citrovorum factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Treatment (bevacizumab and chemoradiotherapy)

OxaliplatinDRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (bevacizumab and chemoradiotherapy)

Radiation TherapyRADIATION

Undergo radiotherapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (bevacizumab and chemoradiotherapy)

Therapeutic Conventional SurgeryPROCEDURE

Undergo surgical resection

Treatment (bevacizumab and chemoradiotherapy)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients must have histologically confirmed, locally advanced, non-metastatic primary T3 or T4 adenocarcinoma of the rectum
Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment to the pelvis
The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by proctoscopic examination
Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following: computed tomography (CT) scan plus endorectal ultrasound, or a magnetic resonance imaging (MRI); an endorectal coil or pelvic MRI is allowed
For the patient to be eligible, the surgeon must prospectively define the tumor as either initially resectable or potentially resectable after pre-operative chemoradiation; clinically resectable tumors are defined as completely resectable with negative margins based on routine examination of the non-anesthetized patient; patients whose tumors are not resectable are not eligible; before pre-operative (op) treatment, the surgeon should estimate and record the type of resection anticipated: pelvic exenteration, posterior pelvic exenteration, APR, LAR, or LAR/coloanal anastomosis
Patients with tumors that are clinically fixed, clinical stage T4N0-2, M0 are eligible if it is believed that their tumors are potentially resectable after chemoradiation; based on the following:
Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum
Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation
Hydronephrosis on CT scan or intravenous pyelogram (IVP) or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate
Vaginal or uterine involvement
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
A surgical evaluation must confirm patient's ability to tolerate the proposed surgical procedure
Patients must have a caloric intake \> 1500 kilocalories/day (d)
Within 4 weeks prior to registration, the patient's absolute neutrophil count (ANC) level must be \>= 1,500/mm\^3
+36 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (107)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

MacNeal Hospital and Cancer Center

Berwyn, Illinois, 60402, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Presence Saint Joseph Hospital-Chicago

Chicago, Illinois, 60657, United States

Location

Saint Anthony Memorial Hospital

Effingham, Illinois, 62401, United States

Location

Hematology Oncology Associates of Illinois-Highland Park

Highland Park, Illinois, 60035, United States

Location

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, 60521, United States

Location

Midwest Center for Hematology Oncology

Joliet, Illinois, 60432, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

NorthShore Hematology Oncology-Libertyville

Libertyville, Illinois, 60048, United States

Location

Garneau, Stewart C MD (UIA Investigator)