Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin
Recruitment status was Active, not recruiting
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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 |
| Estimated Enrollment: | 140 |
| Study Start Date: | August 1998 |
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 |
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| 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
Additional Information:
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 May 22, 2013