Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin - Full Text View

Sponsor:	Academisch Ziekenhuis Maastricht
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003558

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 III

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:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Paclitaxel Etoposide Carboplatin Citrovorum factor Etoposide phosphate Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00003558 History of Changes
Other Study ID Numbers:	CDR0000066622, DUT-KWF-CKVO-9801, EU-98023
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012