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

Genetics Home Reference related topics:   Cancer  

ChemIDplus related topics:   Cisplatin   Gemcitabine hydrochloride   Gemcitabine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 %u2265 1,500/mm3; platelets %u2265 100,000 mm3; bilirubin %u2264 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    
Contact: Karim FIZAZI, Dr     33 1 42114559     fizazi@igr.fr    
France
Institut Gustave Roussy     Recruiting
      Villejuif, France, 94805
      Contact: Karim FIZAZI, Dr     33 1 42114559     fizazi@igr.fr    
Institut Gustave Roussy
Principal Investigator:     Karim FIZAZI, Dr     Institut Gustave Roussy    
  More Information

Study ID Numbers:   GEFCAPI O2
First Received:   August 2, 2005
Last Updated:   September 7, 2006
ClinicalTrials.gov Identifier:   NCT00126269
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  

Study placed in the following topic categories:
Neoplasms, Unknown Primary
Cisplatin
Neoplasm Metastasis
Gemcitabine
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses

Source: National Library of Medicine (NLM) July 03, 2008

  
 
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