NCT00126269

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2005

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

August 2, 2005

Last Update Submit

September 7, 2006

Conditions

Carcinoma

Keywords

Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • Response rate

  • Progression-free survival

  • Toxicity

  • Quality of life

Interventions

cisplatinDRUG
gemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Carcinoma

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Karim FIZAZI, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim FIZAZI, Dr

CONTACT

33 1 42114559fizazi@igr.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 3, 2005

Study Start

May 1, 2003

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

FR(1)