Clinical trial NCT00448136: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: PFS - Time to Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
Secondary outcomes:
measure: Percentage of Participants With a Response by Best Overall Response
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of Overall Response (OR) - Percentage of Participants With an Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of OR - Time to Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of ODC - Time to Event
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months
timeFrame: Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
measure: OS - Time to Event
timeFrame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
measure: OS - Percentage of Participants Surviving at 12 and 24 Months
timeFrame: Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years
measure: Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
timeFrame: Screening, every 3 months during treatment
measure: Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category
timeFrame: Screening, every 3 months during treatment
measure: EORTC QLQ-C30 Functional and Symptom Scale Scores
timeFrame: Screening, every 3 months during treatment
Other outcomes:
Locations:
city: Angers
country: France
city: Bordeaux
country: France
city: Boulogne Billancourt
country: France
city: Caen
country: France
city: Chambray Les Tours
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Reims
country: France
city: Rouen
country: France
city: Saint Brieuc
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: