Testicular CancerPhase 2NCT00531687
Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
A Phase 2 study testing Paclitaxel, Cisplatin and Gemcitabine in people with Testicular Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Study Objectives: Primary objective The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Paclitaxel, Cisplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Oct 2016
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
- Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
- Male
- Age greater than or equal to 18 years;
- Performance status 0,1,2 or 3
- WBC > 3000 mill/l, ANC > 1500 mill/l, platelet count > 100.000 mill/l; serum bilirubin < 1.5 x the upper limit of normal;
- Adequate renal function (Glomerular Filtration Rate (GFR) >60 ml/min). GFR will be assessed by direct measurement (EDTA clearance or creatinine clearance)
- signed informed consent;
Who cannot join
- Uncontrolled active severe clinical infection (CTC grade 3 or 4).
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
- Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.
- Second malignancy other than basal or squamous cell skin cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
Study Objectives:
Primary objective
- The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.
Secondary Objectives
- Overall survival
- Progression free survival
- Response rates (RECIST)
- Duration of response
- To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Read the detailed description
not relevant
- Conditions
- Testicular Cancer
- Being tested
- Paclitaxel, Cisplatin, Gemcitabine
- Keywords
- relapse
- Medical subject headings
- Testicular Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called taxol
Paclitaxel 175 mg/m2 day 1 (3 hour infusion)
Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
CisplatinDrug
cisplatin 50 mg/m2 day 1 and 2
Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered.
GemcitabineDrug
Also called Gemzar
gemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion)
Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered
| Study group | Role | What they receive |
|---|---|---|
| GCT | Other | cisplatin Paclitaxel gemcitabine Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · ·
Measured: December 2010
Secondary outcomes (5)
Secondary Objectives · Overall survival
Measured: 5 years
Secondary Objectives · Progression free survival
Measured: 5 years
Secondary Objectives · Response rates (RECIST)
Measured: 5 years
Secondary Objectives · Duration of response
Measured: 5 years
Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2012
- Study completionOct 2016
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531687
- Sponsor's protocol ID
- Relapse testis cancer 2007
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2007
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer
- ClinicalTrials.gov ID
- NCT00531687
- Acronym / sponsor ID
- Relapse testis cancer 2007
- Conditions
- Testicular Cancer
- Keywords
- relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Sep 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.
Study Objectives:
Primary objective
- The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP.
Secondary Objectives
- Overall survival
- Progression free survival
- Response rates (RECIST)
- Duration of response
- To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Detailed description
not relevant
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCT | Other | Drug: Paclitaxel, Drug: Cisplatin, Drug: Gemcitabinecisplatin Paclitaxel gemcitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed germ cell tumor (seminoma or non-seminoma) with measurable metastatic disease either by radiography (at a site which has previously not been irradiated) or elevation of alpha fetoprotein (AFP) and/or elevation of beta-human chorionic gonadotropin (beta-HCG);
- Patient previously treated with standard BEP (3 or 4 cycles) with relapse 1 months or more after favorable response on previous chemotherapy (CR or PR)
- Male
- Age greater than or equal to 18 years;
- Performance status 0,1,2 or 3
Key exclusion criteria (4 listed)
- Uncontrolled active severe clinical infection (CTC grade 3 or 4).
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), including expected difficulty of follow-up related to mental disorders.
- Grade 2 or greater peripheral neuropathy according to the CTC, version 3.0.
- Second malignancy other than basal or squamous cell skin cancer.
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 |
|---|---|---|
| PaclitaxelAlso: taxolPaclitaxel 175 mg/m2 day 1 (3 hour infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered. | Drug | GCT |
| Cisplatincisplatin 50 mg/m2 day 1 and 2 Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered. | Drug | GCT |
| GemcitabineAlso: Gemzargemcitabine 1000mg/m2 days 1 and 8 (in a 30 minute infusion) Repeat at 21-day intervals for 4 cycles if toxicity is acceptable. If necessary more than 4 cycles can be administered | Drug | GCT |
Primary outcome
Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · ·
Time frame: December 2010
5 secondary outcomes
Secondary Objectives · Overall survival
Time frame: 5 years
Secondary Objectives · Progression free survival
Time frame: 5 years
Secondary Objectives · Response rates (RECIST)
Time frame: 5 years
Secondary Objectives · Duration of response
Time frame: 5 years
Secondary Objectives · To investigate the safety of paclitaxel, gemcitabine and cisplatin in patients previously treated with BEP
Time frame: 5 years
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: No
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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, DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Paclitaxel, Cisplatin and Gemcitabine in people with Testicular Cancer, 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Oct 2017. 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 stopped early (reason given: slow accrual). Results are not available in the source record.
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?
Primary objective · The primary objective of this study is to investigate the combination of cisplatin/gemcitabine/paclitaxel, with respect to complete remission in patients with germ cell tumours previously treated with BEP. · · (time frame: December 2010). 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 3 Oct 2017.