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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: AFSSAPS (Agence francaise de securite sanitaire des produits de sante)

Study ID:

ML20383

NCT ID:

NCT00448136

Start Date:

July 2007

Completion Date:

November 2011

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Endocrine Gland Neoplasms

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