Unknown Primary TumorsPhase 2NCT00458315
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
A Phase 2 study testing Cisplatin, Paclitaxel and Gemcitabine in people with Unknown Primary Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Unknown Primary Tumors
- What is being tested?
- Cisplatin, Paclitaxel and Gemcitabine
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unknown primary tumors
- ECOG performance status 0-1
- Adequate kidney, liver and bone marrow function
- No prior chemotherapy
- Life expectancy > 3 months
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.
Read the 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 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.
- Conditions
- Unknown Primary Tumors
- Being tested
- Cisplatin, Paclitaxel, Gemcitabine, Avastin (Bevacizumab)
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
PaclitaxelDrug
GemcitabineDrug
Avastin (Bevacizumab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Response
Secondary outcomes (2)
Toxicity
Response Duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionMay 2012 (estimated)
Why it stopped: never been started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unknown Primary TumorsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gedske Daugaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gedske Daugaard, MD, Principal investigator, Rigshospitalet, Dept of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458315
- Sponsor's protocol ID
- Cis/Gem/Tax +/- Avastin
- Status last verified
- Sep 2009
- First submitted
- 6 Apr 2007
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
- ClinicalTrials.gov ID
- NCT00458315
- Acronym / sponsor ID
- Cis/Gem/Tax +/- Avastin
- Conditions
- Unknown Primary Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never been started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unknown primary tumors
- ECOG performance status 0-1
- Adequate kidney, liver and bone marrow function
- No prior chemotherapy
- Life expectancy > 3 months
Key exclusion criteria (16 listed)
- The following specific syndromes:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin | Drug | – |
| Paclitaxel | Drug | – |
| Gemcitabine | Drug | – |
| Avastin (Bevacizumab) | Drug | – |
Primary outcome
Progression Free Survival
Response
2 secondary outcomes
Toxicity
Response Duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gedske Daugaard, MD principal investigator
Rigshospitalet, Dept of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Paclitaxel and Gemcitabine in people with Unknown Primary Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.