- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448136
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
January 20, 2015 updated by: Hoffmann-La Roche
An Open Label Study to Evaluate the Effect of Avastin in Association With Chemotherapy on Progression-free Survival in Patients With Progressive Advanced/Metastatic Well-differentiated Digestive Endocrine Tumors of the Gastrointestinal Tract
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated digestive endocrine tumors.
Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks.
Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks.
The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity.
The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angers, France, 49933
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Bordeaux, France, 33075
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Boulogne Billancourt, France, 92104
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Caen, France, 14033
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Chambray Les Tours, France, 37171
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Clichy, France, 92118
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Creteil, France, 94010
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Dijon, France, 21079
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Lille, France, 59020
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Lyon, France, 69437
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Marseille, France, 13285
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Marseille, France, 13385
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Marseille, France, 13273
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Montpellier, France, 34298
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Nantes, France, 44093
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Nice, France, 06189
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Paris, France, 75970
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Paris, France, 75908
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Paris, France, 75651
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Paris, France, 75571
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Poitiers, France, 86021
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Reims, France, 51092
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Rouen, France, 76031
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Saint Brieuc, France, 22015
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Strasbourg, France, 67091
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Toulouse, France, 31059
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Villejuif, France, 94805
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- no previous anti-cancer therapy, other than surgery;
- progressive metastatic disease;
- >=1 measurable lesion.
Exclusion Criteria:
- abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- patients with known bleeding disorders;
- unstable systemic disease;
- chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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7.5mg/kg iv on day 1 every 3 weeks
400mg/m2/day iv on days 1-5 every 6 weeks
500mg/m2/day iv on days 1-5 every 6 weeks
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Experimental: 2
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7.5mg/kg iv on day 1 every 3 weeks
1000mg/m2 po bid on days 1-14 every 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause.
The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
PFS - Time to Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause.
The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
Median PFS was estimated using the Kaplan-Meier method.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause.
The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Response by Best Overall Response
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review.
Complete response (CR): complete disappearance of all target lesions and non-target disease.
All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]).
No new lesions.
Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD).
PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
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Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of Overall Response (OR) - Percentage of Participants With an Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
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Duration of OR - Time to Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Median duration of OR was estimated using the Kaplan-Meier method.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of ODC - Time to Event
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
Median time to event was estimated using the Kaplan-Meier method.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
Time Frame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation without progression.
Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.
|
Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
|
Overall Survival (OS) - Percentage of Participants With an Event
Time Frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
OS was defined as the time from the first treatment administration to death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation.
Data for participants who were alive at the end of the study were censored at the date of last visit.
|
Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
OS - Time to Event
Time Frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
OS was defined as the time from the first treatment administration to death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation.
Data for participants who were alive at the end of the study were censored at the date of last visit.
Median OS was estimated using the Kaplan-Meier method.
|
Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
OS - Percentage of Participants Surviving at 12 and 24 Months
Time Frame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
OS was defined as the time from the first treatment administration to death from any cause.
Data for participants who were lost to follow-up were censored at the date of last evaluation.
Data for participants who were alive at the end of the study were censored at the date of last visit.
|
Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
|
Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Time Frame: Screening, every 3 months during treatment
|
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']).
Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
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Screening, every 3 months during treatment
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Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
Time Frame: Screening, every 3 months during treatment
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']).
Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).
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Screening, every 3 months during treatment
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EORTC QLQ-C30 Functional and Symptom Scale Scores
Time Frame: Screening, every 3 months during treatment
|
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']).
Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning.
For symptom scale scores a higher level represents a more severe level of symptoms.
|
Screening, every 3 months during treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
March 15, 2007
First Submitted That Met QC Criteria
March 15, 2007
First Posted (Estimate)
March 16, 2007
Study Record Updates
Last Update Posted (Estimate)
January 22, 2015
Last Update Submitted That Met QC Criteria
January 20, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibiotics, Antineoplastic
- Bevacizumab
- Streptozocin
Other Study ID Numbers
- ML20383
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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