NCT00458315

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2007

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 8, 2015

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

April 6, 2007

Last Update Submit

May 6, 2015

Conditions

Unknown Primary Tumors

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival

  • Response

Secondary Outcomes (2)

  • Toxicity

  • Response Duration

Interventions

CisplatinDRUG
PaclitaxelDRUG
GemcitabineDRUG
Avastin (Bevacizumab)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unknown primary tumors
  • ECOG performance status 0-1
  • Adequate kidney, liver and bone marrow function
  • No prior chemotherapy
  • Life expectancy \> 3 months

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Dept of Oncology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

CisplatinPaclitaxelGemcitabineBevacizumab

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gedske Daugaard, MD

    Rigshospitalet, Dept of Oncology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 10, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2007

Study Completion

May 1, 2012

Last Updated

May 8, 2015

Record last verified: 2009-09

Locations

DK(1)