A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
Inclusion Criteria:
- Patients older than 18 years
- Evidence of CUP based on histologic examination
- Negative search for the primary tumor site using recommended guidelines
- Disease classified as good prognosis according to the French classification criteria:
*performance status >2 and *normal serum LDH
- No prior chemotherapy
- No previous carcinoma, except basal-cell carcinoma of the skin
- Adequate renal function: measured or calculated creatinine clearance > 60 ml/min
- Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold
the upper normal value
- Signed informed consent
Exclusion Criteria:
- Patients infected by the Human Immunodeficiency Virus (HIV)
- CUP belonging to one of the following subgroups: 1) Axillary lymph node of an
adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3)
Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell
carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum
prostate specific antigen (PSA) in a man
- Patients who do not fit inclusion criteria.