Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.

The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Cisplatin; Gemcitabine

Criteria

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.