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5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00308516
Collaborator
Genentech, Inc. (Industry)
66
Enrollment
14
Locations
2
Arms
71.1
Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rectal cancer. Recent evidence has proven fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

All eligible patients will receive combined modality treatment initially. Systemic treatment will begin 4-6 weeks after completion of the Combined Modality portion and will complete 4 cycles of a 4 week regimen. Patients with no evidence of disease following systemic therapy may continue single agent bevacizumab for up to one year. After all treatment is completed, patients will be re-evaluated with imaging to establish a new baseline. Patients will be re-evaluated thereafter for up to a total of 5 years.

Combined Modality Treatment:

  • bevacizumab 5mg/kg IV infusion days 1, 15, and 29

  • fluorouracil 225mg/m2 IV continuous infusion days 1-42

  • radiation 1.8 Gy/day or 28 fractions weeks 1-6

Systemic Treatment:

  • 5-fluorouracil 400 mg/m2 bolus

  • 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15

  • leucovorin 350 mg prior to FU on days 1 and 15

  • oxaliplatin 85 mg/m2 days 1 and 15

  • bevacizumab 5 mg/kg days 1 and 15

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A - Preoperative

Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.

Drug: 5-Fluorouracil
Combined Modality Treatment: fluorouracil 225mg/m2 IV continuous infusion days 1-42 Systemic Treatment: 5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
Other Names:
  • Fluorouracil
  • Efudex
  • 5-FU

    • Drug: Bevacizumab
    Combined Modality Treatment: bevacizumab 5mg/kg IV infusion days 1, 15, and 29 Systemic Treatment: bevacizumab 5 mg/kg days 1 and 15
    Other Names:
  • Avastin

    • Procedure: Radiation Therapy
    radiation 1.8 Gy/day or 28 fractions weeks 1-6

    Drug: Oxaliplatin
    Systemic Treatment: oxaliplatin 85 mg/m2 days 1 and 15
    Other Names:
  • Eloxatin

    • Drug: Leucovorin
    Systemic Treatment: leucovorin 350 mg prior to FU on days 1 and 15
    Other Names:
  • Folinic acid

    		•
    Experimental: Cohort B - Combined Modality

    All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.

    Drug: 5-Fluorouracil
    Combined Modality Treatment: fluorouracil 225mg/m2 IV continuous infusion days 1-42 Systemic Treatment: 5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
    Other Names:
  • Fluorouracil
  • Efudex
  • 5-FU

    • Drug: Bevacizumab
    Combined Modality Treatment: bevacizumab 5mg/kg IV infusion days 1, 15, and 29 Systemic Treatment: bevacizumab 5 mg/kg days 1 and 15
    Other Names:
  • Avastin

    • Procedure: Radiation Therapy
    radiation 1.8 Gy/day or 28 fractions weeks 1-6

    Drug: Oxaliplatin
    Systemic Treatment: oxaliplatin 85 mg/m2 days 1 and 15
    Other Names:
  • Eloxatin

    • Drug: Leucovorin
    Systemic Treatment: leucovorin 350 mg prior to FU on days 1 and 15
    Other Names:
  • Folinic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment [24 months]

      The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment

    Secondary Outcome Measures

    1. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [24 months]

      Overall Survival (OS) is defined ad the Length of time, in months, that patients were alive from their first date of protocol treatment until death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed Stage I or II rectal cancer

    • Patients must be candidates for preoperative or adjuvant chemoradiation.

    • Patients enrolling in the adjuvant chemoradiation cohort must have undergone surgical resection of the primary rectal tumor between 28 and 56 days (i.e., 4-8 weeks) prior to study treatment.

    • ECOG performance status 0-1

    • Adequate bone marrow, liver, and kidney function

    • At least 18 years of age

    • Able to give written informed consent

    Exclusion Criteria:

    • Treatment with prior chemotherapy or radiation for rectal cancer

    • History of myocardial infarction

    • Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease

    • History of stroke within 6 months

    • History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within 6 months

    • Symptomatic sensory or peripheral neuropathy

    • Prior treatment with anti-angiogenic agents

    • Prior malignancy in the past 5 years

    • Active infections or serious underlying medical condition

    • Major surgery less than 28 days prior

    • Women who are pregnant or lactating

    • Thrombolytic therapy within 10 days of starting bevacizumab

    • PEG tube, G-tube, or external biliary stents

    • Proteinuria

    • Non healing wound, ulcer or fracture

    • History of bleeding diathesis or coagulopathy

    • Hemoptysis

    • Participation in another experimental trial within 28 days

    • Uncontrolled anticoagulant therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northeast Alabama Regional Medical Center Anniston Alabama United States 36207
    2 Northeast Arkansas Clinic Jonesboro Arkansas United States 72401
    3 Florida Cancer Specialists Fort Myers Florida United States 33901
    4 Integrated Community Oncology Network Jacksonville Florida United States 32256
    5 Watson Clinic Center for Cancer Care and Research Lakeland Florida United States 33805
    6 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    7 Wellstar Cancer Research Marietta Georgia United States 30060
    8 Consultants in Blood Disorders and Cancer Louisville Kentucky United States 40207
    9 Consultants in Medical Oncology and Hematology Drexel Hill Pennsylvania United States 19026
    10 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    11 Chattanooga Oncology Hematology Associates Chattanooga Tennessee United States 37404
    12 Tennessee Oncology Nashville Tennessee United States 37205
    13 South Texas Oncology and Hematology San Antonio Texas United States 78258
    14 Peninsula Cancer Institute Newport News Virginia United States 23601

    Sponsors and Collaborators

    • SCRI Development Innovations, LLC
    • Genentech, Inc.

    Investigators

    • Principal Investigator: David R. Spigel, MD, SCRI Development Innovations, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00308516
    Other Study ID Numbers:
    • SCRI GI 65
    • AVF3105s
    First Posted:
    Mar 29, 2006
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by SCRI Development Innovations, LLC
    Rectal Cancer
    Cancer of the Rectum
    Colorectal Cancer
    Bevacizumab
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Rectal Neoplasms
    Leucovorin
    Bevacizumab
    Fluorouracil
    Oxaliplatin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Arm/Group Description Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
    Period Title: Overall Study
    STARTED 35 31
    COMPLETED 6 10
    NOT COMPLETED 29 21

    Baseline Characteristics

    Arm/Group Title Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab Total
    Arm/Group Description Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. Total of all reporting groups
    Overall Participants 35 31 66
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    57
    56
    57
    Sex: Female, Male (Count of Participants)
    Female
    9
    25.7%
    16
    51.6%
    25
    37.9%
    Male
    26
    74.3%
    15
    48.4%
    41
    62.1%
    Region of Enrollment (participants) [Number]
    United States
    35
    100%
    31
    100%
    66
    100%

    Outcome Measures

    1. Primary Outcome
    Title Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
    Description The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Arm/Group Description Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
    Measure Participants 35 31
    Number (95% Confidence Interval) [percentage of participants]
    85
    242.9%
    97
    312.9%
    2. Secondary Outcome
    Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
    Description Overall Survival (OS) is defined ad the Length of time, in months, that patients were alive from their first date of protocol treatment until death.
    Time Frame 24 months

    Outcome Measure Data

    Analysis Population Description
    The median survival was not reached for either of the cohorts
    Arm/Group Title Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Arm/Group Description Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
    Measure Participants 35 31
    Median (95% Confidence Interval) [months]
    NA
    NA

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Arm/Group Description Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle. All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
    All Cause Mortality
    Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/35 (51.4%) 15/31 (48.4%)
    Blood and lymphatic system disorders
    Hemorrhage - Nose 0/35 (0%) 0 1/31 (3.2%) 1
    Cardiac disorders
    Cardiac Ischemia/Infarction 0/35 (0%) 0 1/31 (3.2%) 1
    Gastrointestinal disorders
    Ileus 1/35 (2.9%) 1 0/31 (0%) 0
    Obstruction - GI 2/35 (5.7%) 2 0/31 (0%) 0
    Pain - Rectum 0/35 (0%) 0 1/31 (3.2%) 1
    Fistula, GI 0/35 (0%) 0 1/31 (3.2%) 1
    Perforation, GI 1/35 (2.9%) 1 2/31 (6.5%) 2
    Pain - Abdomen 0/35 (0%) 0 1/31 (3.2%) 1
    Diarrhea 1/35 (2.9%) 1 1/31 (3.2%) 1
    Constipation 1/35 (2.9%) 1 0/31 (0%) 0
    Hematochezia 0/35 (0%) 0 1/31 (3.2%) 1
    Dehydration 0/35 (0%) 0 1/31 (3.2%) 1
    General disorders
    Fever 1/35 (2.9%) 1 0/31 (0%) 0
    Hepatobiliary disorders
    Liver Dysfunction 1/35 (2.9%) 1 0/31 (0%) 0
    Cholecystitis 0/35 (0%) 0 1/31 (3.2%) 1
    Infections and infestations
    Infection - Pelvis 1/35 (2.9%) 1 0/31 (0%) 0
    Infection - NOS 2/35 (5.7%) 2 0/31 (0%) 0
    Infection - GI 0/35 (0%) 0 2/31 (6.5%) 2
    Infection - Skin 1/35 (2.9%) 1 0/31 (0%) 0
    Infection - Postoperative 1/35 (2.9%) 1 0/31 (0%) 0
    Infection - Renal/Genitourinary 1/35 (2.9%) 1 0/31 (0%) 0
    Injury, poisoning and procedural complications
    Overdose 0/35 (0%) 0 1/31 (3.2%) 1
    Metabolism and nutrition disorders
    Hyperglycemia 0/35 (0%) 0 1/31 (3.2%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis 0/35 (0%) 0 1/31 (3.2%) 2
    Nervous system disorders
    Syncope 0/35 (0%) 0 1/31 (3.2%) 1
    Mental Status 0/35 (0%) 0 1/31 (3.2%) 1
    Renal and urinary disorders
    Urinary Frequency 1/35 (2.9%) 1 0/31 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    ARDS 1/35 (2.9%) 1 0/31 (0%) 0
    Hypoxia 0/35 (0%) 0 1/31 (3.2%) 1
    Skin and subcutaneous tissue disorders
    Dermatology - Other 1/35 (2.9%) 1 0/31 (0%) 0
    Wound Complication 0/35 (0%) 0 1/31 (3.2%) 1
    Surgical and medical procedures
    Surgery/Intraoperative Injury - Prostate 1/35 (2.9%) 1 0/31 (0%) 0
    Vascular disorders
    Thrombosis/Thrombus/Embolism 2/35 (5.7%) 2 1/31 (3.2%) 1
    Other (Not Including Serious) Adverse Events
    Preoperative 5FU/Radiation/Bevacizumab Postoperative 5FU/Radiation/Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 35/35 (100%) 31/31 (100%)
    Blood and lymphatic system disorders
    Edema - Limb 0/35 (0%) 0 2/31 (6.5%) 2
    Hemoglobin 22/35 (62.9%) 65 18/31 (58.1%) 47
    Hemorrhage - Gums 0/35 (0%) 0 2/31 (6.5%) 5
    Hemorrhage - Nose 7/35 (20%) 17 6/31 (19.4%) 11
    Platelets 10/35 (28.6%) 27 13/31 (41.9%) 31
    Cardiac disorders
    Hypertension 6/35 (17.1%) 12 7/31 (22.6%) 16
    Hypotension 0/35 (0%) 0 2/31 (6.5%) 4
    Eye disorders
    Watery Eye 3/35 (8.6%) 7 0/31 (0%) 0
    Gastrointestinal disorders
    Anorexia 15/35 (42.9%) 19 11/31 (35.5%) 24
    Constipation 9/35 (25.7%) 21 8/31 (25.8%) 14
    Dehydration 9/35 (25.7%) 10 8/31 (25.8%) 10
    Diarrhea 24/35 (68.6%) 54 27/31 (87.1%) 70
    Dyspepsia 3/35 (8.6%) 13 4/31 (12.9%) 7
    Dysphagia 2/35 (5.7%) 2 0/31 (0%) 0
    Rectal Drainage 2/35 (5.7%) 3 2/31 (6.5%) 2
    Hemorrhage - GI 5/35 (14.3%) 6 5/31 (16.1%) 5
    Hemorrhoids 2/35 (5.7%) 6 0/31 (0%) 0
    Mucositis/Stomatitis 15/35 (42.9%) 19 12/31 (38.7%) 19
    Nausea 17/35 (48.6%) 39 18/31 (58.1%) 38
    Proctitis 2/35 (5.7%) 2 3/31 (9.7%) 4
    Taste Alteration 6/35 (17.1%) 13 4/31 (12.9%) 12
    Vomiting 8/35 (22.9%) 10 10/31 (32.3%) 16
    General disorders
    Rigor/Chills 2/35 (5.7%) 2 0/31 (0%) 0
    Cold Sensitivity 2/35 (5.7%) 2 0/31 (0%) 0
    Fatigue 29/35 (82.9%) 72 22/31 (71%) 66
    Fever 3/35 (8.6%) 3 5/31 (16.1%) 7
    Insomnia 4/35 (11.4%) 11 7/31 (22.6%) 10
    Pain - NOS 25/35 (71.4%) 79 26/31 (83.9%) 81
    Pain - Abdomen 5/35 (14.3%) 8 10/31 (32.3%) 16
    Pain - Back 4/35 (11.4%) 9 0/31 (0%) 0
    Pain - Chest 2/35 (5.7%) 2 0/31 (0%) 0
    Pain - Head 2/35 (5.7%) 4 3/31 (9.7%) 5
    Pain - Rectum 3/35 (8.6%) 3 4/31 (12.9%) 5
    Immune system disorders
    Leukocytes 22/35 (62.9%) 75 21/31 (67.7%) 72
    Neutrophils 14/35 (40%) 32 15/31 (48.4%) 36
    Infections and infestations
    Infection - Postoperative 3/35 (8.6%) 3 0/31 (0%) 0
    Infection - GI 0/35 (0%) 0 3/31 (9.7%) 5
    Infection - Skin 3/35 (8.6%) 3 2/31 (6.5%) 2
    Infection - Upper Respiratory 3/35 (8.6%) 9 3/31 (9.7%) 4
    Infection - Renal/Genitourinary 7/35 (20%) 7 3/31 (9.7%) 3
    Infection with Normal ANC 2/35 (5.7%) 2 5/31 (16.1%) 5
    Metabolism and nutrition disorders
    Alkaline Phosphatase 2/35 (5.7%) 5 4/31 (12.9%) 5
    ALT 2/35 (5.7%) 3 0/31 (0%) 0
    AST 4/35 (11.4%) 9 2/31 (6.5%) 3
    Bilirubin 2/35 (5.7%) 3 0/31 (0%) 0
    Hyperglycemia 10/35 (28.6%) 13 7/31 (22.6%) 29
    Hypoalbuminemia 4/35 (11.4%) 4 2/31 (6.5%) 3
    Hypocalcemia 5/35 (14.3%) 8 2/31 (6.5%) 2
    Hypokalemia 3/35 (8.6%) 3 3/31 (9.7%) 4
    Hyponatremia 2/35 (5.7%) 2 0/31 (0%) 0
    Weight Loss 7/35 (20%) 19 5/31 (16.1%) 12
    Musculoskeletal and connective tissue disorders
    Myalgia 3/35 (8.6%) 5 8/31 (25.8%) 15
    Arthritis 0/35 (0%) 0 6/31 (19.4%) 17
    Nervous system disorders
    Dizziness 0/35 (0%) 0 3/31 (9.7%) 3
    Neuropathy - Motor 0/35 (0%) 0 2/31 (6.5%) 2
    Neuropathy - Sensory 18/35 (51.4%) 58 18/31 (58.1%) 65
    Psychiatric disorders
    Mental Status 0/35 (0%) 0 2/31 (6.5%) 3
    Mood Alteration - Anxiety 5/35 (14.3%) 16 2/31 (6.5%) 2
    Mood Alteration - Depression 4/35 (11.4%) 15 2/31 (6.5%) 2
    Renal and urinary disorders
    Hemorrhage - Hematuria 2/35 (5.7%) 6 0/31 (0%) 0
    Dysuria 4/35 (11.4%) 4 5/31 (16.1%) 5
    Proteinuria 8/35 (22.9%) 29 9/31 (29%) 17
    Urinary Frequency 3/35 (8.6%) 4 0/31 (0%) 0
    Urinary Retention 3/35 (8.6%) 3 0/31 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis 2/35 (5.7%) 2 5/31 (16.1%) 14
    Congestion 2/35 (5.7%) 2 2/31 (6.5%) 5
    Cough 0/35 (0%) 0 5/31 (16.1%) 5
    Dyspnea 2/35 (5.7%) 5 2/31 (6.5%) 4
    Sinusitis 0/35 (0%) 0 2/31 (6.5%) 5
    Voice Changes 2/35 (5.7%) 3 0/31 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 3/35 (8.6%) 4 2/31 (6.5%) 8
    Hand-Foot 4/35 (11.4%) 7 3/31 (9.7%) 8
    Irritation 0/35 (0%) 0 2/31 (6.5%) 2
    Nail Changes 2/35 (5.7%) 3 0/31 (0%) 0
    Dermatitis 4/35 (11.4%) 5 2/31 (6.5%) 2
    Rash/Desquamation 8/35 (22.9%) 18 10/31 (32.3%) 12
    Ulceration 7/35 (20%) 10 0/31 (0%) 0
    Urticaria 0/35 (0%) 0 2/31 (6.5%) 6
    Wound Complication 2/35 (5.7%) 2 3/31 (9.7%) 3
    Vascular disorders
    Thrombosis/Thrombus/Embolism 9/35 (25.7%) 16 4/31 (12.9%) 6

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.

    Results Point of Contact

    Name/Title John Hainsworth, MD
    Organization Sarah Cannon Research Institute
    Phone 1-877-691-7274
    Email asksarah@scresearch.net
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00308516
    Other Study ID Numbers:
    • SCRI GI 65
    • AVF3105s
    First Posted:
    Mar 29, 2006
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Nov 1, 2021