Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003558
Recruitment Status : Unknown
Verified February 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for cancer of unknown primary origin.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin.

Condition or disease Intervention/treatment Phase
Carcinoma of Unknown Primary Drug: carboplatin Drug: etoposide Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Phase 3

Detailed Description:


  • Compare the overall survival after treatment with paclitaxel, carboplatin, and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary.
  • Compare the response rates, progression free survival, toxicity profile, and quality of life between the two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence or absence of liver metastases.

Patients are randomly assigned to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to four courses.
  • Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two courses.

Patients are followed every 3 months after treatment for 1 year or until death. Quality of life questionnaires are completed at each follow-up.

PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
Study Start Date : August 1998

Information from the National Library of Medicine

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


  • Histologically confirmed adenocarcinoma of any differentiation grade

    • Excludes the following "treatable" conditions:

      • Axillary node involvement
      • Peritonitis carcinomatosis
      • Blastic bone metastases and/or elevated PSA
      • Squamous cell cancer with cervical or inguinal presentation
      • Poorly differentiated carcinoma

        • Neuroendocrine tumors OR
        • Tumors located in the mediastinum, retroperitoneum, or nodes
  • At least one measurable metastatic site
  • No brain or meningeal metastases



  • Over 18

Performance status:

  • ECOG 0-2


  • Leukocyte count at least 4,000/mm3
  • Thrombocyte count at least 100,000/mm3


  • Bilirubin less than 1.4 mg/dL
  • AST and ALT less than 3 times upper limit of normal
  • No cirrhosis of the liver


  • Creatinine less than 1.7 mg/dL


  • At least 3 months since myocardial infarction
  • No congestive heart failure, tachydysrhythmia, or unstable angina pectoris


  • Not pregnant or nursing
  • Negative pregnancy test
  • No active infection
  • No other serious illness or medical condition
  • No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow)


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003558

Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
Sponsors and Collaborators
Academisch Ziekenhuis Maastricht
Study Chair: R. L. Jansen, MD, PhD Academisch Ziekenhuis Maastricht Identifier: NCT00003558     History of Changes
Other Study ID Numbers: DUT-KWF-CKVO-9801
CDR0000066622 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: February 2003

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of unknown primary
newly diagnosed carcinoma of unknown primary

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Etoposide phosphate
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors