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

Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00126269
• Other study ID #: GEFCAPI O2
• Status: Recruiting
• Phase: Phase 3
• First received: August 2, 2005
• Last updated: September 7, 2006
• Start date: May 2003

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Karim FIZAZI, Dr
• Phone: 33 1 42114559
• Email: fizazi[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Unknown Primary

Intervention

Drug:
• cisplatin

• gemcitabine

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Response rate
Secondary	Progression-free survival
Secondary	Toxicity
Secondary	Quality of life