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

Tracking Information

First Received Date ^ICMJE

August 2, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00126269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response rate
Progression-free survival
Toxicity
Quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Carcinoma

Intervention ^ICMJE

Drug: cisplatin
Drug: gemcitabine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

192

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Karim FIZAZI, Dr

33 1 42114559

fizazi@igr.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00126269

Responsible Party

Study ID Numbers ^ICMJE

GEFCAPI O2

Study Sponsor ^ICMJE

Institut Gustave Roussy

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Karim FIZAZI, Dr

Institut Gustave Roussy

Information Provided By

Institut Gustave Roussy

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP