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

NCT ID: NCT00458315

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-05-31

Brief Summary

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

Detailed Description

Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

Arm A: Cisplatin, Paclitaxel and Gemcitabine

• Cisplatin 75 mg/m2 IV infusion, Day 1
• Paclitaxel 175 mg/m2 IV infusion, Day 1
• Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8

Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab)

• Cisplatin 75 mg/m2 IV infusion, Day 1
• Paclitaxel 175 mg/m2 IV infusion, Day 1
• Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
• Bevacizumab 7,5 mg/m2 IV infusion, Day 1

Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high).

The regimens will be repeated every 21 days.

Conditions

Unknown Primary Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cisplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Avastin (Bevacizumab)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Gedske Daugaard

dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gedske Daugaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Dept of Oncology

Locations

Rigshospitalet, Dept of Oncology

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

Cis/Gem/Tax +/- Avastin

Identifier Type: -

Identifier Source: org_study_id