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

This study has been withdrawn prior to enrollment.
(never been started)
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark Identifier:
First received: April 6, 2007
Last updated: May 6, 2015
Last verified: September 2009
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

Condition Intervention Phase
Unknown Primary Tumors Drug: Cisplatin Drug: Paclitaxel Drug: Gemcitabine Drug: Avastin (Bevacizumab) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors

Resource links provided by NLM:

Further study details as provided by Gedske Daugaard, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Progression Free Survival
  • Response

Secondary Outcome Measures:
  • Toxicity
  • Response Duration

Enrollment: 0
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00458315

Rigshospitalet, Dept of Oncology
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Gedske Daugaard, MD Rigshospitalet, Dept of Oncology
  More Information

Responsible Party: Gedske Daugaard, dr., Rigshospitalet, Denmark Identifier: NCT00458315     History of Changes
Other Study ID Numbers: Cis/Gem/Tax +/- Avastin
Study First Received: April 6, 2007
Last Updated: May 6, 2015

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on July 25, 2017