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

Primary Purpose

Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cisplatin
gemcitabine
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Gustave RoussyRecruiting

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Response rate
Progression-free survival
Toxicity
Quality of life

Full Information

First Posted
August 2, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00126269
Brief Title
Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma
Keywords
Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Response rate
Title
Progression-free survival
Title
Toxicity
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim FIZAZI, Dr
Phone
33 1 42114559
Email
fizazi@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, Dr
Phone
33 1 42114559
Email
fizazi@igr.fr

12. IPD Sharing Statement

Learn more about this trial

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

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