Randomized fase II trial: comparing Cisplatin, Paclitaxel and Gemcitabine vs. Cisplatin, Paclitaxel, Gemcitabine and Avastin in patients with unknown primary tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000663-18-DK

Enrollment

120

Registered

2007-02-27

Start date

2007-03-08

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

To test in a randomized fase II trial the effect of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin in patients with unknown primary tumors between the age of 18 and 70 years old and with a perfomance status 0-1

Interventions

Trade Name: Cisplatin Product Name: Cisplatin Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CISPLATIN CAS Number: 15663271 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: unknown primary tumor Performance status 0-1 Age between 18 and 70 years old Measurable lesion by RECIST Life expectancy > 3 months Sufficient organ functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Performance status > 1 older than 70 years old Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding Use of ASA, NSAIDs or clopidogrel Any other active malignancy, except basal or squamous cell carcinoma of the skin, or carcinoma in situ

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Response rate Progression free survival;Main Objective: 1. Response rate 2. Progression free survival;Secondary Objective: 1. Toxicity 2. Survival 3. Response duration	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026