Randomized Fase II Study: Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00458315

Purpose

The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Bevacizumab in patients with unknown primary tumors

Condition	Intervention	Phase
Unknown Primary Tumors	Drug: Cisplatin Drug: Paclitaxel Drug: Gemcitabine Drug: Bevacizumab	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Progression Free Survival
Response

Secondary Outcome Measures:

Toxicity
Response Duration

Estimated Enrollment:	120
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2012

Detailed Description:

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458315

Contacts

Contact: Anne Kirstine H Møller, MD, PhD student	+45 35 45 09 90	anne.kirstine.moeller@rh.regionh.dk
Contact: Gedske Daugaard, MD	+45 35 45 46 77	gedske@rh.regionh.dk

Locations

Denmark
Rigshospitalet, Dept of Oncology
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Gedske Daugaard, MD

Rigshospitalet, Dept of Oncology

More Information

Study ID Numbers:	Cis/Gem/Tax +/- Avastin
Study First Received:	April 6, 2007
Last Updated:	April 6, 2007
ClinicalTrials.gov Identifier:	NCT00458315
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Neoplasms, Unknown Primary
Cisplatin
Paclitaxel

Neoplasm Metastasis
Bevacizumab
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Angiogenesis Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplastic Processes
Neoplasms
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009