Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003558
First received: November 1, 1999
Last updated: August 6, 2013
Last verified: February 2003
  Purpose

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 Intervention Phase
Carcinoma of Unknown Primary
Drug: carboplatin
Drug: etoposide
Drug: fluorouracil
Drug: leucovorin calcium
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 140
Study Start Date: August 1998
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 1.7 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified
  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: NCT00003558

Locations
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022 GC
Sponsors and Collaborators
Academisch Ziekenhuis Maastricht
Investigators
Study Chair: R. L. Jansen, MD, PhD Academisch Ziekenhuis Maastricht
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003558     History of Changes
Other Study ID Numbers: DUT-KWF-CKVO-9801, CDR0000066622, EU-98023
Study First Received: November 1, 1999
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Etoposide
Paclitaxel
Etoposide phosphate
Fluorouracil
Carboplatin
Leucovorin
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex

ClinicalTrials.gov processed this record on August 27, 2014