A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country192 target enrollmentMay 2003

ConditionsCarcinoma

Drugscisplatin gemcitabine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Carcinoma
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 192
Locations: 1
Primary Endpoint: Overall survival
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Eligibility 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.