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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00458315
First received: April 6, 2007
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Progression Free Survival
  • Response

Secondary Outcome Measures:
  • Toxicity
  • Response Duration

Estimated Enrollment: 120
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458315

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

No publications provided

ClinicalTrials.gov Identifier: NCT00458315     History of Changes
Other Study ID Numbers: Cis/Gem/Tax +/- Avastin
Study First Received: April 6, 2007
Last Updated: September 21, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Bevacizumab
Cisplatin
Gemcitabine
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014