Urinary Tract CancerPhase 2NCT02006667

A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

A Phase 2 study testing trastuzumab, gemcitabine and cisplatin in people with Urinary Tract Cancer, run by Hoffmann-La Roche at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Tract Cancer
What is being tested?: trastuzumab, gemcitabine and cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 7 sitesGermany
Study dates: Jan 2001to Jan 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients with >=18 years of age;
metastatic urothelial carcinoma;
measurable metastases or local recurrent disease;
no prior chemotherapy for metastatic disease;
HER2 overexpression (IHC [2+] or [3+]).

Who cannot join

concomitant chemotherapy or immunotherapy;
active or uncontrolled infection;
solely CNS metastases;
clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Germany7 sites

Study site
Aschersleben, 06449
Study site
Dessau, 06846
Study site
Fulda, 36043
Study site
Leipzig, 04103
Study site
Leipzig, 04277
Study site
Marburg, 35043
Study site
Weiden, 92637

Other trials in Germany

About this study

Official title: An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer

Conditions: Urinary Tract Cancer
Being tested: trastuzumab, gemcitabine, cisplatin
Medical subject headings: Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

trastuzumabDrug
Also called Herceptin
4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression
gemcitabineDrug
1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6
cisplatinDrug
70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Study groups in NCT02006667
Study group	Role	What they receive
Trastuzumab, Gemcitabine, Cisplatin	Experimental	Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6. Receives: Drug: trastuzumab; Drug: gemcitabine; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Measured: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Progression-Free Survival - Time to Event
The median time, in months, from the first dose of study treatment to PFS event.
Measured: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Percentage of Participants Who Were Progression Free at 12 and 24 Months
Measured: Screening, and Months 12 and 24

Secondary outcomes (4)

Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the start of study treatment to date of death due to any cause.
Measured: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Overall Survival - Time to Event
The median time, in months, from the start of study treatment to OS event.
Measured: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Percentage of Participants Surviving at 12 and 24 Months
Measured: Screening, and Months 12 and 24
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).
Measured: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Jan 2010

First posted10 Dec 2013 (estimated)
Study startJan 2001
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary Tract CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02006667
Sponsor's protocol ID: ML17600
Status last verified: Feb 2015
First submitted: 5 Dec 2013
Last updated: 11 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer
ClinicalTrials.gov ID: NCT02006667
Acronym / sponsor ID: ML17600
Conditions: Urinary Tract Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2001
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 10 Dec 2013 (estimated)
Results: Posted 11 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trastuzumab, Gemcitabine, Cisplatin	Experimental	Drug: trastuzumab, Drug: gemcitabine, Drug: cisplatinParticipants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

adult patients with >=18 years of age;
metastatic urothelial carcinoma;
measurable metastases or local recurrent disease;
no prior chemotherapy for metastatic disease;
HER2 overexpression (IHC [2+] or [3+]).

Key exclusion criteria (5 listed)

concomitant chemotherapy or immunotherapy;
active or uncontrolled infection;
solely CNS metastases;
clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

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
trastuzumabAlso: Herceptin4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression	Drug	Trastuzumab, Gemcitabine, Cisplatin
gemcitabine1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6	Drug	Trastuzumab, Gemcitabine, Cisplatin
cisplatin70 mg/m2 i.v. on Day 2 of Cycles 1 through 6	Drug	Trastuzumab, Gemcitabine, Cisplatin

Primary outcome

Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Progression-Free Survival - Time to Event
Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
The median time, in months, from the first dose of study treatment to PFS event.
Percentage of Participants Who Were Progression Free at 12 and 24 Months
Time frame: Screening, and Months 12 and 24

4 secondary outcomes

Overall Survival (OS) - Percentage of Participants With an Event
Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Overall Survival - Time to Event
Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
Percentage of Participants Surviving at 12 and 24 Months
Time frame: Screening, and Months 12 and 24
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Results and safety

Results posted to the registry on 11 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trastuzumab/Gemcitabine/Cisplatin	13	7

Primary outcome: Progression-Free Survival (PFS) - Percentage of Participants With an Event

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months. Number. Unit: percentage of participants

Measure	Trastuzumab/Gemcitabine/Cisplatin n = 13
Value	92.3

Population analysed: FAS

Primary outcome: Progression-Free Survival - Time to Event

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months. Median (95% Confidence Interval). Unit: months

Measure	Trastuzumab/Gemcitabine/Cisplatin n = 13
Value	11.0 (5.7 to 14.3)

Population analysed: FAS

Primary outcome: Percentage of Participants Who Were Progression Free at 12 and 24 Months

Time frame: Screening, and Months 12 and 24. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Trastuzumab/Gemcitabine/Cisplatin n = 13
12 Months	38.5 (14.1 to 62.8)
24 Months	15.4 (2.5 to 38.8)

Population analysed: FAS

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from randomization until 30 days after the end of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trastuzumab/Gemcitabine/Cisplatin	8 of 13 (61.5%)	9 of 13 (69.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Trials study director

Hoffmann-La Roche

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, gemcitabine and cisplatin in people with Urinary Tract Cancer, run by Hoffmann-La Roche at 7 sites in Germany.

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 5 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: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS) - Percentage of Participants With an Event (time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02006667.

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 11 Feb 2015.