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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Unknown Primary Tumors

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Unknown primary tumors

2. ECOG performance status 0-1

3. Adequate kidney, liver and bone marrow function

4. No prior chemotherapy

5. Life expectancy > 3 months

Exclusion Criteria:

1. 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

2. Tumor located close to major blood vessels and judged to possess a high risk of
serious bleeding

3. Any significant cardiac disease

4. Clinically significant peripheral vascular disease

5. History of myocardial infarction or stroke within 6 months

6. Evidence of coagulopathy

7. Use of ASA, NSAIDs or clopidogrel

8. Pregnancy or breast feeding

9. Ongoing therapeutic anti-coagulation

10. Hypertension with blood pressure > 150/100 mmHg

11. Brain metastases

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival

Principal Investigator

Gedske Daugaard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Dept of Oncology

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

Cis/Gem/Tax +/- Avastin

NCT ID:

NCT00458315

Start Date:

May 2007

Completion Date:

May 2012

Related Keywords:

  • Unknown Primary Tumors
  • Neoplasms, Unknown Primary

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