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

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2006

First Received: August 2, 2005 Last Updated: September 7, 2006 History of Changes

Sponsor:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00126269

Purpose

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.

Condition	Intervention	Phase
Carcinoma	Drug: cisplatin Drug: gemcitabine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

Response rate
Progression-free survival
Toxicity
Quality of life

Estimated Enrollment:	192
Study Start Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126269

Contacts

Contact: Karim FIZAZI, Dr

33 1 42114559

fizazi@igr.fr

Locations

France
Institut Gustave Roussy	Recruiting
Villejuif, France, 94805
Contact: Karim FIZAZI, Dr 33 1 42114559 fizazi@igr.fr

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Principal Investigator:

Karim FIZAZI, Dr

Institut Gustave Roussy

More Information

No publications provided

Study ID Numbers:	GEFCAPI O2
Study First Received:	August 2, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00126269 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms, Unknown Primary
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplastic Processes
Pathologic Processes
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Neoplasm Metastasis
Gemcitabine
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on March 18, 2010