Status:
UNKNOWN
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00126269
Start Date
May 1 2003
Last Update
September 8 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Gustave Roussy
Villejuif, France, 94805