Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

Detailed Description
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Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: Arm A: Cisplatin, Paclitaxel and Gemcitabine Cisplatin 75 mg/m2 IV infusion, Day 1 Paclitaxel 175 mg/m2 IV infusion, Day 1 Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8 Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab) Cisplatin 75 mg/m2 IV infusion, Day 1 Paclitaxel 175 mg/m2 IV infusion, Day 1 Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8 Bevacizumab 7,5 mg/m2 IV infusion, Day 1 Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high). The regimens will be repeated every 21 days.

Official Title
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Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors

Conditions
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Unknown Primary Tumors

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Paclitaxel
* Drug: Gemcitabine
* Drug: Avastin (Bevacizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unknown primary tumors ECOG performance status 0-1 Adequate kidney, liver and bone marrow function No prior chemotherapy Life expectancy > 3 months Exclusion Criteria: The following specific syndromes: Squamous carcinoma limited to cervical glands Women with adenocarcinoma isolated to axillary nodes Women with adenocarcinoma isolated to peritoneal involvements Young men (<55 years) with growing mid-line tumors where a germ cell tumor could be expected Neuroendocrine carcinomas Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding Any significant cardiac disease Clinically significant peripheral vascular disease History of myocardial infarction or stroke within 6 months Evidence of coagulopathy Use of ASA, NSAIDs or clopidogrel Pregnancy or breast feeding Ongoing therapeutic anti-coagulation Hypertension with blood pressure > 150/100 mmHg Brain metastases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cisplatin|nan|
|Drug: Paclitaxel|nan|
|Drug: Gemcitabine|nan|
|Drug: Avastin (Bevacizumab)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  |  | 
| Response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Response Duration |  |  |