A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer

Not Applicable

• Conditions: -C259 Pancreas, unspecified; Pancreas, unspecified; C259

• Registration Number: PER-045-05
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age> 18 years.
2. Able to comply with the protocol.
3. Kamofsky Performance Status> 60%.
4. Life expectancy of> 8 weeks.
5. Free and informed consent in writing.
6. Pancreatic cancer (adenocarcinoma) histologically or cytologically documented with metastatic disease (stage IV) measurable or not measurable according to the sixth edition of the TNM classification.
7. Function of proper bone marrow
8. INR <1.5 and aPTT <1.5 x ULN within 7 days prior to randomization.
9. Adequate liver function.
10. Adequate renal function.

Exclusion Criteria

1. Local pancreatic cancer (Stage IA to IIB) and locally advanced pancreatic cancer (stage III).
2. Previous adjuvant radiotherapy for pancreatic cancer.
3. Less than (or equal to) six months from the last adjuvant chemotherapy.
4. Previous systemic therapy for metastatic pancreatic cancer.
5. Another primary tumor (including primary brain tumors) within the last 5 years prior to randomization.
6. Evidence of compression of the spinal column or current evidence of CNS metastasis.
7. History or evidence, in the neurological examination, of other CNS diseases.
8. Evidence based on CT scan of tumor invading main blood vessels.
9. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment.
10. Current or newly used chronic aspirin.
11. Current or recently used chronic full therapeutic dose of oral or parenteral anticoagulants or thrombolytic agents.
12. Uncontrolled hypertension or clinically significant cardiovascular disease.
13. History or evidence of inherited blood diathesis or coagulopathy with the risk of bleeding.
14. Wound not healing, ulcer, or bone fracture, patients with esophageal varices.
15. Any significant known ophthalmological abnormalities of the eye surface.
16. Inability to take medication orally.
17. Pregnant women or breastfeeding.
18. Men and women of maternity potential not using effective means of contraception.
19. Current or newly treated with another investigational drug or participation in another research study.
20. Evidence of any other disease, metabolic dysfunction, result of physical examination or clinical laboratory result giving reasonable suspicion of a disease or condition that contraindicates the use of a research drug or patient at high risk of treatment complications.
21. Known hypersensitivity to any of the study drugs or their ingredients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified