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| Sponsored by: |
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: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 140 |
| Study Start Date: | August 1998 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of any differentiation grade
Excludes the following "treatable" conditions:
Poorly differentiated carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| St. Elisabeth Ziekenhuis | |
| Tilburg, Netherlands, 5022 GC | |
| Study Chair: | R. L. Jansen, MD, PhD | Academisch Ziekenhuis Maastricht |
More Information
| Study ID Numbers: | CDR0000066622, DUT-KWF-CKVO-9801, EU-98023 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003558 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of unknown primary newly diagnosed carcinoma of unknown primary |
|
Antimetabolites Immunologic Factors Leucovorin Folate Etoposide phosphate Vitamin B9 Vitamins Neoplasm Metastasis Micronutrients Etoposide Neoplasms, Unknown Primary Vitamin B Complex Trace Elements |
Carboplatin Antimitotic Agents Folinic Acid Immunosuppressive Agents Carcinoma Folic Acid Calcium, Dietary Paclitaxel Fluorouracil Tubulin Modulators Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leucovorin Neoplastic Processes Pathologic Processes Therapeutic Uses Vitamins Neoplasm Metastasis Micronutrients Etoposide Neoplasms, Unknown Primary |
Neoplasms by Histologic Type Vitamin B Complex Growth Substances Mitosis Modulators Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Fluorouracil Tubulin Modulators Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |