Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
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|ClinicalTrials.gov 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
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|
- 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|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00003558
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|St. Elisabeth Ziekenhuis|
|Tilburg, Netherlands, 5022 GC|
|Study Chair:||R. L. Jansen, MD, PhD||Academisch Ziekenhuis Maastricht|