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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00126269
• Collaborator: (none)
• Enrollment: 192
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma	Drug: cisplatin; Drug: gemcitabine	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2003

Outcome Measures

Primary Outcome Measures

1. Overall survival []

Secondary Outcome Measures

1. Response rate []

2. Progression-free survival []

3. Toxicity []

4. Quality of life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

• Principal Investigator: Karim FIZAZI, Dr, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00126269
• Other Study ID Numbers: GEFCAPI O2
• First Posted: Aug 3, 2005
• Last Update Posted: Sep 8, 2006
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: Patients with Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
• Additional relevant MeSH terms: Carcinoma; Gemcitabine

Study Results

No Results Posted as of Sep 8, 2006