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

Unknown Primary Tumors Clinical Trial

Official title:

Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00458315
• Other study ID #: Cis/Gem/Tax +/- Avastin
• Status: Withdrawn
• Phase: Phase 2
• First received: April 6, 2007
• Last updated: May 6, 2015
• Start date: May 2007
• Est. completion date: May 2012

Study information

• Verified date: September 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neoplasms, Unknown Primary
• Unknown Primary Tumors

Intervention

Drug:
• Cisplatin

• Paclitaxel

• Gemcitabine

• Avastin (Bevacizumab)

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Dept of Oncology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival
Primary	Response
Secondary	Toxicity
Secondary	Response Duration