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Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00588770
Recruitment Status : Active, not recruiting
First Posted : January 9, 2008
Results First Posted : November 15, 2019
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neck Squamous Cell Carcinoma of Unknown Primary
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Salivary Gland Carcinoma
Recurrent Sinonasal Squamous Cell Carcinoma
Salivary Gland Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Major Salivary Gland Cancer AJCC v7
Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Laryngeal Verrucous Carcinoma AJCC v7
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVA Major Salivary Gland Cancer AJCC v7
Stage IVA Oral Cavity Cancer AJCC v6 and v7
Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7
Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Laryngeal Verrucous Carcinoma AJCC v7
Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVB Major Salivary Gland Cancer AJCC v7
Stage IVB Oral Cavity Cancer AJCC v6 and v7
Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7
Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Laryngeal Verrucous Carcinoma AJCC v7
Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IVC Major Salivary Gland Cancer AJCC v7
Stage IVC Oral Cavity Cancer AJCC v6 and v7
Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7
Tongue Carcinoma
Interventions Biological: Bevacizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Docetaxel
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Enrollment 403
Recruitment Details E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.
Pre-assignment Details  
Arm/Group Title Chemotherapy Arm (Arm A) Chemotherapy+Bevacizumab (Arm B)
Hide Arm/Group Description

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Period Title: Overall Study
Started 200 203
Eligible 188 183
Start Protocol Therapy 200 194
Completed 41 3
Not Completed 159 200
Reason Not Completed
Disease progression             85             68
Adverse Event             29             58
Death             13             22
Withdrawal by Subject             15             25
Alternative therapy             2             4
Other complicating disease             3             2
Not start protocol therapy             0             9
Lack of Efficacy             8             10
Physician discretion             2             0
Patient non-compliance             2             2
Arm/Group Title Chemotherapy Arm (Arm A) Chemotherapy+Bevacizumab (Arm B) Total
Hide Arm/Group Description

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Total of all reporting groups
Overall Number of Baseline Participants 200 203 403
Hide Baseline Analysis Population Description
All randomized patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 200 participants 203 participants 403 participants
58
(32 to 86)
58
(29 to 82)
58
(29 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 203 participants 403 participants
Female
32
  16.0%
27
  13.3%
59
  14.6%
Male
168
  84.0%
176
  86.7%
344
  85.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 203 participants 403 participants
White
168
  84.0%
179
  88.2%
347
  86.1%
Black
21
  10.5%
18
   8.9%
39
   9.7%
Other
4
   2.0%
2
   1.0%
6
   1.5%
Not reported
7
   3.5%
4
   2.0%
11
   2.7%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.
Time Frame assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Chemotherapy Arm (Arm A) Chemotherapy+Bevacizumab (Arm B)
Hide Arm/Group Description:

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

Regimen 2:

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Regimen 2 carbo:

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Overall Number of Participants Analyzed 200 203
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.5 to 13.0)
12.6
(10.3 to 15.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chemotherapy Arm (Arm A), Chemotherapy+Bevacizumab (Arm B)
Comments The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.
Time Frame on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Chemotherapy Arm (Arm A) Chemotherapy+Bevacizumab (Arm B)
Hide Arm/Group Description:

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

Regimen 2:

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Regimen 2 carbo:

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Overall Number of Participants Analyzed 200 203
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(3.8 to 5.2)
6.0
(4.9 to 6.7)
3.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).
Time Frame on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Chemotherapy Arm (Arm A) Chemotherapy+Bevacizumab (Arm B)
Hide Arm/Group Description:

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

Regimen 2:

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

Regimen 2 carbo:

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

Overall Number of Participants Analyzed 200 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.245
(0.187 to 0.311)
0.355
(0.289 to 0.425)
4.Other Pre-specified Outcome
Title To Collect Blood Samples Before and After Therapy for Future Correlative Studies
Hide Description These were blood and tissue samples collections and have no data to report.
Time Frame Before and after therapy
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title To Collect Tumor Tissue Samples Available at Baseline From Prior Diagnostic Procedures for Future Correlative Studies
Hide Description These were blood and tissue samples collections and have no data to report.
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
Adverse Event Reporting Description

At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population.

A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.

 
Arm/Group Title Chemotherapy (Arm A) Chemotherapy + Bevacizumab (Arm B)
Hide Arm/Group Description

ARM A: Patients receive one of the four chemotherapy regimens

ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A

ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.

ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.

ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.

ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.

All-Cause Mortality
Chemotherapy (Arm A) Chemotherapy + Bevacizumab (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   182/200 (91.00%)   175/203 (86.21%) 
Hide Serious Adverse Events
Chemotherapy (Arm A) Chemotherapy + Bevacizumab (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   135/199 (67.84%)   162/193 (83.94%) 
Blood and lymphatic system disorders     
Anemia  1  17/199 (8.54%)  9/193 (4.66%) 
Febrile neutropenia  1  19/199 (9.55%)  35/193 (18.13%) 
Cardiac disorders     
Asystole  1  0/199 (0.00%)  1/193 (0.52%) 
Atrial fibrillation  1  0/199 (0.00%)  2/193 (1.04%) 
Cardiac arrest  1  1/199 (0.50%)  2/193 (1.04%) 
Chest pain - cardiac  1  0/199 (0.00%)  1/193 (0.52%) 
Left ventricular systolic dysfunction  1  1/199 (0.50%)  0/193 (0.00%) 
Myocardial infarction  1  0/199 (0.00%)  1/193 (0.52%) 
Supraventricular tachycardia  1  0/199 (0.00%)  1/193 (0.52%) 
Ventricular arrhythmia  1  0/199 (0.00%)  1/193 (0.52%) 
Ear and labyrinth disorders     
Hearing impaired  1  1/199 (0.50%)  1/193 (0.52%) 
Tinnitus  1  1/199 (0.50%)  0/193 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/199 (0.50%)  7/193 (3.63%) 
Colitis  1  0/199 (0.00%)  2/193 (1.04%) 
Colonic perforation  1  0/199 (0.00%)  1/193 (0.52%) 
Constipation  1  1/199 (0.50%)  0/193 (0.00%) 
Diarrhea  1  1/199 (0.50%)  9/193 (4.66%) 
Duodenal hemorrhage  1  0/199 (0.00%)  1/193 (0.52%) 
Dyspepsia  1  0/199 (0.00%)  1/193 (0.52%) 
Dysphagia  1  1/199 (0.50%)  9/193 (4.66%) 
Esophageal fistula  1  0/199 (0.00%)  2/193 (1.04%) 
Esophagitis  1  1/199 (0.50%)  1/193 (0.52%) 
Gastric hemorrhage  1  0/199 (0.00%)  3/193 (1.55%) 
Gastric perforation  1  0/199 (0.00%)  1/193 (0.52%) 
Gastrointestinal pain  1  0/199 (0.00%)  1/193 (0.52%) 
Mucositis oral  1  8/199 (4.02%)  37/193 (19.17%) 
Nausea  1  15/199 (7.54%)  22/193 (11.40%) 
Oral hemorrhage  1  0/199 (0.00%)  4/193 (2.07%) 
Oral pain  1  0/199 (0.00%)  1/193 (0.52%) 
Small intestinal obstruction  1  1/199 (0.50%)  1/193 (0.52%) 
Stomach pain  1  0/199 (0.00%)  1/193 (0.52%) 
Vomiting  1  9/199 (4.52%)  14/193 (7.25%) 
Gastrointestinal disorders - Other  1  1/199 (0.50%)  2/193 (1.04%) 
General disorders     
Death NOS  1  1/199 (0.50%)  2/193 (1.04%) 
Edema face  1  1/199 (0.50%)  0/193 (0.00%) 
Edema limbs  1  2/199 (1.01%)  1/193 (0.52%) 
Fatigue  1  20/199 (10.05%)  34/193 (17.62%) 
Non-cardiac chest pain  1  0/199 (0.00%)  1/193 (0.52%) 
Pain  1  0/199 (0.00%)  1/193 (0.52%) 
Sudden death NOS  1  0/199 (0.00%)  1/193 (0.52%) 
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify  1  0/199 (0.00%)  1/193 (0.52%) 
Immune system disorders     
Anaphylaxis  1  1/199 (0.50%)  1/193 (0.52%) 
Immune system disorders - Other, specify  1  0/199 (0.00%)  1/193 (0.52%) 
Infections and infestations     
Abdominal infection  1  0/199 (0.00%)  1/193 (0.52%) 
Cranial nerve infection  1  1/199 (0.50%)  0/193 (0.00%) 
Enterocolitis infectious  1  0/199 (0.00%)  1/193 (0.52%) 
Gum infection  1  0/199 (0.00%)  2/193 (1.04%) 
Kidney infection  1  0/199 (0.00%)  1/193 (0.52%) 
Lung infection  1  3/199 (1.51%)  5/193 (2.59%) 
Mucosal infection  1  1/199 (0.50%)  0/193 (0.00%) 
Salivary gland infection  1  1/199 (0.50%)  0/193 (0.00%) 
Sepsis  1  0/199 (0.00%)  3/193 (1.55%) 
Skin infection  1  2/199 (1.01%)  3/193 (1.55%) 
Soft tissue infection  1  0/199 (0.00%)  1/193 (0.52%) 
Tracheitis  1  1/199 (0.50%)  1/193 (0.52%) 
Wound infection  1  1/199 (0.50%)  2/193 (1.04%) 
Infections and infestations - Other  1  3/199 (1.51%)  6/193 (3.11%) 
Injury, poisoning and procedural complications     
Injury to carotid artery  1  0/199 (0.00%)  1/193 (0.52%) 
Tracheal hemorrhage  1  0/199 (0.00%)  1/193 (0.52%) 
Tracheostomy site bleeding  1  0/199 (0.00%)  2/193 (1.04%) 
Vascular access complication  1  1/199 (0.50%)  1/193 (0.52%) 
Wound dehiscence  1  0/199 (0.00%)  1/193 (0.52%) 
Investigations     
Alanine aminotransferase increased  1  1/199 (0.50%)  3/193 (1.55%) 
Aspartate aminotransferase increased  1  1/199 (0.50%)  1/193 (0.52%) 
Creatinine increased  1  1/199 (0.50%)  2/193 (1.04%) 
Lymphocyte count decreased  1  12/199 (6.03%)  12/193 (6.22%) 
Neutrophil count decreased  1  53/199 (26.63%)  73/193 (37.82%) 
Platelet count decreased  1  13/199 (6.53%)  15/193 (7.77%) 
Weight loss  1  4/199 (2.01%)  5/193 (2.59%) 
White blood cell decreased  1  33/199 (16.58%)  51/193 (26.42%) 
Investigations - Other, specify  1  1/199 (0.50%)  0/193 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  13/199 (6.53%)  12/193 (6.22%) 
Dehydration  1  11/199 (5.53%)  30/193 (15.54%) 
Hypoalbuminemia  1  0/199 (0.00%)  1/193 (0.52%) 
Hypocalcemia  1  2/199 (1.01%)  2/193 (1.04%) 
Hypokalemia  1  8/199 (4.02%)  5/193 (2.59%) 
Hypomagnesemia  1  1/199 (0.50%)  1/193 (0.52%) 
Hyponatremia  1  5/199 (2.51%)  7/193 (3.63%) 
Hypophosphatemia  1  1/199 (0.50%)  6/193 (3.11%) 
Metabolism and nutrition - Other  1  0/199 (0.00%)  1/193 (0.52%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/199 (0.00%)  1/193 (0.52%) 
Back pain  1  0/199 (0.00%)  1/193 (0.52%) 
Bone pain  1  1/199 (0.50%)  1/193 (0.52%) 
Generalized muscle weakness  1  1/199 (0.50%)  4/193 (2.07%) 
Muscle weakness lower limb  1  0/199 (0.00%)  1/193 (0.52%) 
Myalgia  1  0/199 (0.00%)  2/193 (1.04%) 
Neck pain  1  0/199 (0.00%)  1/193 (0.52%) 
Osteonecrosis of jaw  1  0/199 (0.00%)  2/193 (1.04%) 
Pain in extremity  1  0/199 (0.00%)  1/193 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms - Other  1  0/199 (0.00%)  2/193 (1.04%) 
Nervous system disorders     
Ataxia  1  0/199 (0.00%)  1/193 (0.52%) 
Dizziness  1  0/199 (0.00%)  1/193 (0.52%) 
Peripheral motor neuropathy  1  0/199 (0.00%)  2/193 (1.04%) 
Peripheral sensory neuropathy  1  4/199 (2.01%)  4/193 (2.07%) 
Reversible posterior leukoencephalopathy  1  0/199 (0.00%)  1/193 (0.52%) 
Seizure  1  0/199 (0.00%)  1/193 (0.52%) 
Syncope  1  3/199 (1.51%)  5/193 (2.59%) 
Nervous system disorders - Other  1  0/199 (0.00%)  2/193 (1.04%) 
Psychiatric disorders     
Confusion  1  0/199 (0.00%)  1/193 (0.52%) 
Depression  1  1/199 (0.50%)  0/193 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  3/199 (1.51%)  3/193 (1.55%) 
Proteinuria  1  0/199 (0.00%)  3/193 (1.55%) 
Renal and urinary disorders - Other  1  0/199 (0.00%)  1/193 (0.52%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/199 (0.00%)  1/193 (0.52%) 
Bronchopulmonary hemorrhage  1  0/199 (0.00%)  1/193 (0.52%) 
Dyspnea  1  1/199 (0.50%)  1/193 (0.52%) 
Hiccups  1  1/199 (0.50%)  0/193 (0.00%) 
Hoarseness  1  0/199 (0.00%)  1/193 (0.52%) 
Hypoxia  1  1/199 (0.50%)  0/193 (0.00%) 
Laryngeal edema  1  0/199 (0.00%)  1/193 (0.52%) 
Laryngeal hemorrhage  1  1/199 (0.50%)  1/193 (0.52%) 
Laryngeal mucositis  1  0/199 (0.00%)  2/193 (1.04%) 
Pharyngeal fistula  1  0/199 (0.00%)  1/193 (0.52%) 
Pharyngeal hemorrhage  1  0/199 (0.00%)  1/193 (0.52%) 
Pharyngeal mucositis  1  1/199 (0.50%)  1/193 (0.52%) 
Pharyngolaryngeal pain  1  4/199 (2.01%)  5/193 (2.59%) 
Pleural effusion  1  0/199 (0.00%)  1/193 (0.52%) 
Pneumonitis  1  0/199 (0.00%)  2/193 (1.04%) 
Pneumothorax  1  0/199 (0.00%)  1/193 (0.52%) 
Respiratory failure  1  0/199 (0.00%)  2/193 (1.04%) 
Respiratory thoracic mediastinal - Other  1  2/199 (1.01%)  0/193 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/199 (0.50%)  0/193 (0.00%) 
Pain of skin  1  0/199 (0.00%)  1/193 (0.52%) 
Palmar-plantar erythrodysesthesia  1  2/199 (1.01%)  0/193 (0.00%) 
Rash maculo-papular  1  1/199 (0.50%)  0/193 (0.00%) 
Vascular disorders     
Hypertension  1  0/199 (0.00%)  12/193 (6.22%) 
Hypotension  1  3/199 (1.51%)  4/193 (2.07%) 
Thromboembolic event  1  1/199 (0.50%)  10/193 (5.18%) 
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy (Arm A) Chemotherapy + Bevacizumab (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   50/199 (25.13%)   50/193 (25.91%) 
General disorders     
Fatigue  1  13/199 (6.53%)  19/193 (9.84%) 
Investigations     
Platelet count decreased  1  9/199 (4.52%)  10/193 (5.18%) 
Metabolism and nutrition disorders     
Anorexia  1  6/199 (3.02%)  13/193 (6.74%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  28/199 (14.07%)  24/193 (12.44%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  19/199 (9.55%)  11/193 (5.70%) 
1
Term from vocabulary, CTCAE 4.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study statistician
Organization: ECOG-ACRIN Cancer Reserch Group Statistical Office
Phone: 6176323012
EMail: eatrials@jimmy.harvard.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00588770    
Other Study ID Numbers: NCI-2009-00507
NCI-2009-00507 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E1305
CDR0000582533
E1305 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1305 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: December 28, 2007
First Posted: January 9, 2008
Results First Submitted: September 18, 2019
Results First Posted: November 15, 2019
Last Update Posted: January 12, 2021