Urothelial CancerPhase 2NCT00821327

Gemzar, Cisp, Sunitinib Urothelial Ca

A Phase 2 study testing Gemcitabine, Cisplatin, Sunitinib in people with Urothelial Cancer, run by US Oncology Research at 48 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urothelial Cancer
What is being tested?: Gemcitabine, Cisplatin, Sunitinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 48 sitesUnited States
Study dates: Aug 2008to Aug 2012
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

Has histological documentation of diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (histology may be mixed, but still requires a component of TCC; measurable disease only)
Has unresectable or metastatic disease
Has a Karnofsky Performance Status greater than or equal 60 percent
Is 18 years of age or older
Has laboratory values as defined by the protocol
Has resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE (v3.0) Grade less than or equal to 1

Show all 11Show fewer

Has normal cardiac function as evidenced by a LVEF greater than or equal to 50 percent, as determined by multiple gated acquisition (MUGA) scan or an echocardiogram (ECHO). The same method must be used throughout the study to evaluate LVEF.
Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopausal])
Is not currently breastfeeding
If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
Has signed a Patient Informed Consent Form, Has signed a Patient Authorization Form

Who cannot join

Has had prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
Has had major surgery or radiation therapy within 4 weeks of starting the study treatment
Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment
Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Has ongoing cardiac dysrhythmias of NCI CTCAE (Version 3.0) Grade 2

Show all 21Show fewer

Has prolonged QTc interval on baseline EKG
Has uncontrolled hypertension (grater than 150/100 mm Hg despite optimal medical therapy)
Has pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Has known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
Is receiving concomitant use of any other investigational drugs or has received such drug within 28 days prior to registration
Is receiving concurrent treatment on another clinical trial, including supportive care
Has ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for thromboembolic prophylaxis allowed). Patients on warfarin (greater than 2mg) for thrombosis must be switched to low molecular weight heparin (ie, Lovenox), prior to registration for protocol therapy.
Is currently taking drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to Day 1 of Cycle 1 (dosing) (and throughout study)
Is currently on CYP3A4 inhibitors (see Section 5) within 7 days prior to Day 1 of Cycle 1 (dosing), with the exception of amiodarone, which should be discontinued within 6 months prior to Day 1 of Cycle 1 (dosing)
Is currently on CYP3A4 inducers (see Section 5) within 14 days prior to Day 1 of Cycle 1 (dosing)
Has been taking herbal or alternative medications within the past 7 days or refuses to discontinue the use of herbal or alternative therapies within 7 days prior to Day 1 of Cycle 1 (dosing)
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
Is a pregnant or nursing woman. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the Study Investigator or Treating Physician. Male patients must be surgically sterile or agree to use effective contraception.
Is unable to comply with requirements of study

Trial locations and contacts

48 sites in 1 country.

City, postcode or hospital

48 sites in 1 country

United States48 sites

Texas Cancer Center - Abilene
Abilene, Texas, 79606
New York Oncology Hematology, P.C.
Albany, New York, 12206
Texas Oncology, P.A. -Amarillo
Amarillo, Texas, 79106
Texas Cancer Center
Arlington, Texas, 76014
Texas Oncology - Round Rock Cancer Center
Austin, Texas, 78731
Mamie McFaddin Ward Cancer Center, Texas Oncology
Beaumont, Texas, 77702
Texas Oncology, P.A. - Bedford
Bedford, Texas, 76022
Highline Medical Oncology
Burien, Washington, 98166
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611
Missouri Cancer Associates
Columbia, Missouri, 65201
Texas Oncology
Dallas, Texas, 75230
Texas Oncology/Methodist Charlton Cancer Ctr.
Dallas, Texas, 75237
Texas Oncology, P.A.
Dallas, Texas, 75246
Texas Cancer Center
Denton, Texas, 76210
Pudget Sound Cancer Center
Edmonds, Washington, 98026
El Paso Cancer Treatment Center - East
El Paso, Texas, 79915
Texas Oncology
Fort Worth, Texas, 76104
Texas Oncology
Garland, Texas, 75042-5788
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Longview Cancer Center
Longview, Texas, 75601
South Texas Cancer Center
McAllen, Texas, 78503
Advanced Medical Specialties
Miami, Florida, 33176
Texas Oncology, PA, Allison Cancer Center
Midland, Texas, 79701
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607
Arch Medical Services, Inc.
Saint Louiis, Missouri, 63141
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Cancer Care Centers of South Texas-HOAST
San Antonio, Texas, 78229
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
Texas Cancer Center - Sherman
Sherman, Texas, 75090
Cancer Care Northwest
Spokane, Washington, 99202
Willamette Valley Cancer Center
Springfield, Oregon, 97477
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, 77479
Arizona Oncology Associates
Tucson, Arizona, 85704
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712
Deke Slayton Cancer Center
Webster, Texas, 77598
Alliance Hematology Oncology PA.
Westminster, Maryland, 21157

Other trials in United States

About this study

Official title: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma

Read the detailed description

Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted.

Conditions: Urothelial Cancer
Being tested: Gemcitabine, Cisplatin, Sunitinib

What participants receive

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

Gemcitabine, Cisplatin, SunitinibDrug
Also called Gemzar, Sutent
Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.
1. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.
2. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.

Study groups in NCT00821327
Study group	Role	What they receive
Study Arm	Experimental	Gemcitabine, Cisplatin, Sunitinib Receives: Drug: Gemcitabine, Cisplatin, Sunitinib

What is being measured

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

Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Measured: 2 years

Secondary outcomes (2)

Progression-free Survival
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Measured: 2 years
Ovarall Survival (OS)
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Measured: 2 years

Timeline

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

Aug 2008Aug 2012

First posted13 Jan 2009 (estimated)
Study startAug 2008
Primary completionAug 2012
Study completionAug 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Urothelial CancerStudies of the same condition, open and under way.
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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00821327
Sponsor's protocol ID: 06040
Other IDs: WS356467
Status last verified: Sep 2016
First submitted: 9 Jan 2009
Last updated: 25 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8.
PubMed 23228446

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

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
Bladder Cancer, Urothelial Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer

All Urothelial Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma
ClinicalTrials.gov ID: NCT00821327
Acronym / sponsor ID: 06040
Conditions: Urothelial Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: US Oncology ResearchIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Aug 2008
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 Jan 2009 (estimated)
Results: Posted 2 Mar 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Arm	Experimental	Drug: Gemcitabine, Cisplatin, SunitinibGemcitabine, Cisplatin, Sunitinib

Who may qualify

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

Key inclusion criteria (11 listed)

Has histological documentation of diagnosis of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (histology may be mixed, but still requires a component of TCC; measurable disease only)
Has unresectable or metastatic disease
Has a Karnofsky Performance Status greater than or equal 60 percent
Is 18 years of age or older
Has laboratory values as defined by the protocol

Key exclusion criteria (21 listed)

Has had prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
Has had major surgery or radiation therapy within 4 weeks of starting the study treatment
Has had NCI CTCAE (Version 3.0) Grade 3-4 hemorrhage within 4 weeks of starting the study treatment
Has a history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
Has had any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism

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
Gemcitabine, Cisplatin, SunitinibAlso: Gemzar, SutentPatients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle. 2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy. 3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity.	Drug	Study Arm

Primary outcome

Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.
Time frame: 2 years
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

2 secondary outcomes

Progression-free Survival
Time frame: 2 years
Ovarall Survival (OS)
Time frame: 2 years

Results and safety

Results posted to the registry on 2 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Arm: Advanced/Metastatic UC	36	1

Primary outcome: Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.

Time frame: 2 years. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Study Arm: Advanced/Metastatic UC n = 33
Value	48.5 (30.8 to 66.5)

Population analysed: All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the whole treatment period, up to 30 days following last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Arm: Advanced/Metastatic UC	7 of 33 (21.2%)	32 of 33 (97%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23228446Galsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8.

Related trials for Urothelial Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Active, not recruitingPhase 3
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
Bladder Cancer, Urothelial Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer

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.

Guru Sonpavde, MD principal investigator

US Oncology

Thomas E Hutson, DO principal investigator

US Oncology

48 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 Gemcitabine, Cisplatin, Sunitinib in people with Urothelial Cancer, run by US Oncology Research at 48 sites in United States.

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 11 inclusion and 21 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. 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 2 Mar 2016). 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?

Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib. (time frame: 2 years). 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 NCT00821327, which also lists 1 linked publication.

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 25 Oct 2016.