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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126269

Enrollment

192

Registered

2005-08-03

Start date

2003-05-31

Completion date

Unknown

Last updated

2006-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma

Keywords

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.

Interventions

DRUGcisplatin

DRUGgemcitabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Response rate	—
Progression-free survival	—
Toxicity	—
Quality of life	—

Countries

France

Contacts

Primary ContactKarim FIZAZI, Dr

fizazi@igr.fr33 1 42114559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026