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Trial record 42 of 2066 for:    Pancreatic Cancer AND Digestive System Neoplasms

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.

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ClinicalTrials.gov Identifier: NCT00448136
Recruitment Status : Completed
First Posted : March 16, 2007
Results First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: bevacizumab [Avastin] Drug: 5 FU Drug: Streptozotocin Drug: Xeloda Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2007
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 every 3 weeks

Drug: 5 FU
400mg/m2/day iv on days 1-5 every 6 weeks

Drug: Streptozotocin
500mg/m2/day iv on days 1-5 every 6 weeks

Experimental: 2 Drug: bevacizumab [Avastin]
7.5mg/kg iv on day 1 every 3 weeks

Drug: Xeloda
1000mg/m2 po bid on days 1-14 every 3 weeks




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 ]
    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).

  13. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448136


Locations
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France
Angers, France, 49933
Bordeaux, France, 33075
Boulogne Billancourt, France, 92104
Caen, France, 14033
Chambray Les Tours, France, 37171
Clichy, France, 92118
Creteil, France, 94010
Dijon, France, 21079
Lille, France, 59020
Lyon, France, 69437
Marseille, France, 13273
Marseille, France, 13285
Marseille, France, 13385
Montpellier, France, 34298
Nantes, France, 44093
Nice, France, 06189
Paris, France, 75571
Paris, France, 75651
Paris, France, 75908
Paris, France, 75970
Poitiers, France, 86021
Reims, France, 51092
Rouen, France, 76031
Saint Brieuc, France, 22015
Strasbourg, France, 67091
Toulouse, France, 31059
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448136     History of Changes
Other Study ID Numbers: ML20383
First Posted: March 16, 2007    Key Record Dates
Results First Posted: January 22, 2015
Last Update Posted: January 22, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Bevacizumab
Streptozocin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antibiotics, Antineoplastic