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

Gustave Roussy

Status and phase

Unknown

Phase 3

Conditions

Carcinoma

Treatments

Drug: cisplatin

Drug: gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00126269

GEFCAPI O2

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.