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

NCT00448136 | Completed Phase 2 Results

• 1 other identifier: ML20383
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 27

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival (PFS) - Percentage of Participants With an Event

  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

  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

  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 Outcomes (13)

• Percentage of Participants With a Response by Best Overall Response

  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

  Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

• Duration of OR - Time to Event

  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

  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

  Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

Study Arms (2)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: 5 FU; Drug: Streptozotocin

2

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: Xeloda

Interventions

bevacizumab [Avastin] DRUG

7.5mg/kg iv on day 1 every 3 weeks

1; 2

5 FU DRUG

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

1

Streptozotocin DRUG

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

1

Xeloda DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (27)

Unknown Facility

Angers, 49933, France

Location

Unknown Facility

Bordeaux, 33075, France

Location

Unknown Facility

Boulogne-Billancourt, 92104, France

Location

Unknown Facility

Caen, 14033, France

Location

Unknown Facility

Chambray-lès-Tours, 37171, France

Location

Unknown Facility

Clichy, 92118, France

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Unknown Facility

Créteil, 94010, France

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Unknown Facility

Dijon, 21079, France

Location

Unknown Facility

Lille, 59020, France

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Unknown Facility

Lyon, 69437, France

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Unknown Facility

Marseille, 13273, France

Location

Unknown Facility

Marseille, 13285, France

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Unknown Facility

Marseille, 13385, France

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Unknown Facility

Montpellier, 34298, France

Location

Unknown Facility

Nantes, 44093, France

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Unknown Facility

Nice, 06189, France

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Unknown Facility

Paris, 75571, France

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Unknown Facility

Paris, 75651, France

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Unknown Facility

Paris, 75908, France

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Unknown Facility

Paris, 75970, France

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Unknown Facility

Poitiers, 86021, France

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Unknown Facility

Reims, 51092, France

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Unknown Facility

Rouen, 76031, France

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Unknown Facility

Saint-Brieuc, 22015, France

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Unknown Facility

Strasbourg, 67091, France

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Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab; Streptozocin; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 16, 2007
• Study Start: July 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 22, 2015
• Results First Posted: January 22, 2015

Record last verified: 2015-01

Locations

FR (27)