Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

Academisch Ziekenhuis Maastricht

Status and phase

Unknown

Phase 3

Conditions

Carcinoma of Unknown Primary

Treatments

Drug: leucovorin calcium

Drug: paclitaxel

Drug: carboplatin

Drug: etoposide

Drug: fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00003558

EU-98023

CDR0000066622 (Registry Identifier)

DUT-KWF-CKVO-9801

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: