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Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

Primary Purpose

Carcinoma of Unknown Primary

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
carboplatin
etoposide
fluorouracil
leucovorin calcium
paclitaxel
Sponsored by
Academisch Ziekenhuis Maastricht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academisch Ziekenhuis Maastricht
  • St. Elisabeth Ziekenhuis

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 6, 2013
Sponsor
Academisch Ziekenhuis Maastricht
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1. Study Identification

Unique Protocol Identification Number
NCT00003558
Brief Title
Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
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 Type
Interventional

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Unknown status
Study Start Date
August 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Academisch Ziekenhuis Maastricht

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary
Keywords
adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. L. Jansen, MD, PhD
Organizational Affiliation
Academisch Ziekenhuis Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands

12. IPD Sharing Statement

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Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

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