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

May 6, 2015 updated by: Gedske Daugaard, Rigshospitalet, Denmark

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Dept of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response
Progression Free Survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Response Duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Gedske Daugaard, MD, Rigshospitalet, Dept of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 6, 2007

First Submitted That Met QC Criteria

April 6, 2007

First Posted (Estimate)

April 10, 2007

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cis/Gem/Tax +/- Avastin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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