Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor

• Status: Withdrawn
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Cisplatin; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Unknown primary tumors

2. ECOG performance status 0-1

3. Adequate kidney, liver and bone marrow function

4. No prior chemotherapy

5. Life expectancy > 3 months

Exclusion Criteria:

1. The following specific syndromes:

• Squamous carcinoma limited to cervical glands

• Women with adenocarcinoma isolated to axillary nodes

• Women with adenocarcinoma isolated to peritoneal involvements

• Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected

• Neuroendocrine carcinomas

2. Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding

3. Any significant cardiac disease

4. Clinically significant peripheral vascular disease

5. History of myocardial infarction or stroke within 6 months

6. Evidence of coagulopathy

7. Use of ASA, NSAIDs or clopidogrel

8. Pregnancy or breast feeding

9. Ongoing therapeutic anti-coagulation

10. Hypertension with blood pressure > 150/100 mmHg

11. Brain metastases