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

Primary Purpose

Unknown Primary Tumors

Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cisplatin
Paclitaxel
Gemcitabine
Avastin (Bevacizumab)
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unknown Primary Tumors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, Dept of Oncology

Outcomes

Primary Outcome Measures

Progression Free Survival
Response

Secondary Outcome Measures

Toxicity
Response Duration

Full Information

First Posted
April 6, 2007
Last Updated
May 6, 2015
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00458315
Brief Title
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
Official Title
Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Withdrawn
Why Stopped
never been started
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unknown Primary Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Avastin (Bevacizumab)
Primary Outcome Measure Information:
Title
Progression Free Survival
Title
Response
Secondary Outcome Measure Information:
Title
Toxicity
Title
Response Duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unknown primary tumors ECOG performance status 0-1 Adequate kidney, liver and bone marrow function No prior chemotherapy Life expectancy > 3 months Exclusion Criteria: 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 Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding Any significant cardiac disease Clinically significant peripheral vascular disease History of myocardial infarction or stroke within 6 months Evidence of coagulopathy Use of ASA, NSAIDs or clopidogrel Pregnancy or breast feeding Ongoing therapeutic anti-coagulation Hypertension with blood pressure > 150/100 mmHg Brain metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gedske Daugaard, MD
Organizational Affiliation
Rigshospitalet, Dept of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Dept of Oncology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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