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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Karim FIZAZI, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GEFCAPI O2

NCT ID:

NCT00126269

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Carcinoma
  • Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
  • Carcinoma
  • Neoplasms, Unknown Primary

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