Urinary Bladder NeoplasmsPhase 1/2NCT01342172
Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma
A Phase 1/2 study testing Lenalidomide in people with Urinary Bladder Neoplasms, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommended dose in subjects… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 1/2
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years at the time of consent.
- Karnofsky Performance Status of ≥ 70%.
- Histological or cytological proof of transitional cell carcinoma of the urothelial tract. The primary site may include: urethra, bladder, ureters, and renal pelvis. Patients with mixed histologies may be enrolled provided that transitional cell carcinoma is the predominant histology.
- Measurable disease according to RECIST or unresectable disease (cT4b).
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
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- Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Adequate organ function as determined by the following laboratory values:
- Hemoglobin (Hgb) > 9 g/dL
- Platelets > 100 x 1,000,000,000/L
- Absolute neutrophil count (ANC) > 1.5 x 1,000,000,000/L
- Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 1.5 X ULN (< 5 X ULN if patient has hepatic metastases)
Who cannot join
- Has had prior treatment with systemic chemotherapy for metastatic disease (prior intravesical therapy is permitted; prior neoadjuvant/adjuvant chemotherapy permitted if completed ≥ 1 year from study entry)
- Has received prior lenalidomide.
- Has had major surgery within 30 days of starting the study treatment
- 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 active CNS metastases. Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
- Has a history of a prior malignancy
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- Has received anticancer therapy, radiation, or any investigational agent within 30 days prior to being registered for protocol therapy.
- Pregnant or breastfeeding.
- Has a clinically significant infection as judged by the treating investigator.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Cancer Institute
Bethesda, Maryland, 20892
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Multi-Center Phase Ib/II Trial of Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma
The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommended dose in subjects to evaluate progression-free survival at 1 year. The secondary objectives will be to determine the objective response rate to treatment, and the safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to evaluate lenalidomide as maintenance treatment in subjects achieving objective response or stable disease.
Read the detailed description
Urothelial carcinoma of the urinary bladder is the second most common genitourinary malignancy. Based on the results of a large randomized study comparing MVAC with gemcitabine plus cisplatin, the latter regimen became a treatment standard based on improved tolerability. While the tolerability of chemotherapy for patients with advanced urothelial carcinoma has improved, there have been no significant improvements in efficacy since the advent of MVAC in the 1980's and novel approaches are clearly needed.
The current study will explore the safety and activity of lenalidomide in combination with gemcitabine plus cisplatin as first line chemotherapy in subjects with metastatic urothelial carcinoma.
The primary objective of the phase Ib portion will be to determine the recommended phase II dose of the combination of gemcitabine, cisplatin, plus lenalidomide in patients with advanced/metastatic urothelial carcinoma. The primary objective of the phase II portion will be the progression-free survival at 1 year. The secondary objectives are to evaluate the activity (as determined by objective response rate); and to determine the safety (per the Common Terminology for Adverse Events version 4.0) of combination therapy with gemcitabine, cisplatin plus lenalidomide; to evaluate lenalidomide as maintenance treatment in patients achieving an objective response or stable disease following completion of 6 cycles of combination therapy and; to determine the impact of treatment on peripheral blood immune cell subsets and circulating tumor cells.
Patients will receive gemcitabine 1000 mg/m2 IV on days 1 + 8 and cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Lenalidomide will be given orally on days 1-14 and the dose will be escalated in successive cohorts during the phase Ib portion to define the recommended phase II dose. Patients will continue gemcitabine, cisplatin, plus lenalidomide for up to 6 cycles, in the absence of disease progression or prohibitive toxicity. After completion of 6 cycles of therapy, patients who have achieved at least "stable disease" will proceed with "maintenance" lenalidomide given orally on days 1-21 of each 28-day cycle. Treatment will continue, in the absence of prohibitive toxicity, until the time of disease progression.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Lenalidomide
- Keywords
- Bladder Cancer, Urothelial Cancer, Chemotherapy, First-line, Metastatic
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Patients will receive gemcitabine 1000 mg/m2 IV on days 1 + 8 and cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Lenalidomide will be given orally on days 1-14 and the dose will be escalated in successive cohorts during the phase Ib portion to define the recommended phase II dose. Patients will continue gemcitabine, cisplatin, plus lenalidomide for up to 6 cycles, in the absence of disease progression or prohibitive toxicity. After completion of 6 cycles of therapy, patients who have achieved at least "stable disease" will proceed with "maintenance" lenalidomide given orally on days 1-21 of each 28-day cycle. Treatment will continue, in the absence of prohibitive toxicity, until the time of disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | capsules for oral administration Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Lenalidomide
MTD was determined by testing planned increasing doses up to 25 mg daily dose on days 1-14, starting at 10mg. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any lenalidomide-related Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) Grade 3 or 4 adverse events
Measured: after 1 cycle (each cycle is 21 days)
Phase II: Progression-free Survival at 1 Year
Measured: 1 year
Secondary outcomes (5)
The Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide
The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR) Disappearance of all target lesions for a period of at least one month.
Partial Response (PR) At least a 30% decrease in the sum of the longest diameter of measures lesions (target lesions), taking as reference the baseline sum of the longest diameter.
Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started.
Progressive Disease (PD) A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Measured: After 2 cycles (a cycle is 21 days)
Number of Grade >=3 Adverse Events
Number of grade >=3 adverse events to assess the safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.
Measured: Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide
Best Overall Response
Best Overall Response to evaluate lenalidomide as maintenance treatment in patients achieving an objective response of either complete response or partial response following completion of 6 cycles of combination therapy.
Complete Response (CR) - CR of target lesions and no new lesions Partial Response (PR) -PR of target lesions and no new lesions Stable Disease (SD) - SD of target lesions and no new lesions Progression Disease (PD) - any status of target lesions and new lesions
Measured: 168 days
To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets
To determine the changes in cellular immunity with lenalidomide in peripheral blood mononuclear cells including Tregs, NK, NKT cells (Berg et al JCO 2010), sIl-2R, TNF alpha (Bartlett et al BJC 2004) and markers indicative of activation, i.e. CD107a. These analyses will only be done in the phase II portion of the protocol.
Measured: Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)
To Determine the Impact of Treatment on Circulating Tumor Cells
Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.
Measured: Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: low accrual
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 Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Principal investigator, Matthew Galsky, Icahn School of Medicine at Mount Sinai
- Investigators
- Matthew Galsky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342172
- Sponsor's protocol ID
- GCO 10-1339
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2011
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Agarwal N, Apolo AB, Tsao CK, Lee KM, Godbold JH, Soto R, Poole A, Gimpel-Tetra K, Lowe N, Oh WK, Galsky MD. Phase Ib/II trial of gemcitabine, cisplatin, and lenalidomide as first-line therapy in patients with metastatic urothelial carcinoma. Oncologist. 2014 Sep;19(9):915-6. doi: 10.1634/theoncologist.2014-0153. Epub 2014 Jul 22.
PubMed 25052451
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Phase Ib/II Trial of Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT01342172
- Acronym / sponsor ID
- GCO 10-1339
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Bladder Cancer, Urothelial Cancer, Chemotherapy, First-line, Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 26 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are (Phase 1) to determine in subjects with unresectable or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to study this recommended dose in subjects to evaluate progression-free survival at 1 year. The secondary objectives will be to determine the objective response rate to treatment, and the safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to evaluate lenalidomide as maintenance treatment in subjects achieving objective response or stable disease.
Detailed description
Urothelial carcinoma of the urinary bladder is the second most common genitourinary malignancy. Based on the results of a large randomized study comparing MVAC with gemcitabine plus cisplatin, the latter regimen became a treatment standard based on improved tolerability. While the tolerability of chemotherapy for patients with advanced urothelial carcinoma has improved, there have been no significant improvements in efficacy since the advent of MVAC in the 1980's and novel approaches are clearly needed.
The current study will explore the safety and activity of lenalidomide in combination with gemcitabine plus cisplatin as first line chemotherapy in subjects with metastatic urothelial carcinoma.
The primary objective of the phase Ib portion will be to determine the recommended phase II dose of the combination of gemcitabine, cisplatin, plus lenalidomide in patients with advanced/metastatic urothelial carcinoma. The primary objective of the phase II portion will be the progression-free survival at 1 year. The secondary objectives are to evaluate the activity (as determined by objective response rate); and to determine the safety (per the Common Terminology for Adverse Events version 4.0) of combination therapy with gemcitabine, cisplatin plus lenalidomide; to evaluate lenalidomide as maintenance treatment in patients achieving an objective response or stable disease following completion of 6 cycles of combination therapy and; to determine the impact of treatment on peripheral blood immune cell subsets and circulating tumor cells.
Patients will receive gemcitabine 1000 mg/m2 IV on days 1 + 8 and cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Lenalidomide will be given orally on days 1-14 and the dose will be escalated in successive cohorts during the phase Ib portion to define the recommended phase II dose. Patients will continue gemcitabine, cisplatin, plus lenalidomide for up to 6 cycles, in the absence of disease progression or prohibitive toxicity. After completion of 6 cycles of therapy, patients who have achieved at least "stable disease" will proceed with "maintenance" lenalidomide given orally on days 1-21 of each 28-day cycle. Treatment will continue, in the absence of prohibitive toxicity, until the time of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomidecapsules for oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years at the time of consent.
- Karnofsky Performance Status of ≥ 70%.
- Histological or cytological proof of transitional cell carcinoma of the urothelial tract. The primary site may include: urethra, bladder, ureters, and renal pelvis. Patients with mixed histologies may be enrolled provided that transitional cell carcinoma is the predominant histology.
- Measurable disease according to RECIST or unresectable disease (cT4b).
Key exclusion criteria (10 listed)
- Has had prior treatment with systemic chemotherapy for metastatic disease (prior intravesical therapy is permitted; prior neoadjuvant/adjuvant chemotherapy permitted if completed ≥ 1 year from study entry)
- Has received prior lenalidomide.
- Has had major surgery within 30 days of starting the study treatment
- 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 active CNS metastases. Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
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 |
|---|---|---|
| LenalidomideAlso: RevlimidPatients will receive gemcitabine 1000 mg/m2 IV on days 1 + 8 and cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Lenalidomide will be given orally on days 1-14 and the dose will be escalated in successive cohorts during the phase Ib portion to define the recommended phase II dose. Patients will continue gemcitabine, cisplatin, plus lenalidomide for up to 6 cycles, in the absence of disease progression or prohibitive toxicity. After completion of 6 cycles of therapy, patients who have achieved at least "stable disease" will proceed with "maintenance" lenalidomide given orally on days 1-21 of each 28-day cycle. Treatment will continue, in the absence of prohibitive toxicity, until the time of disease progression. | Drug | Lenalidomide |
Primary outcome
Maximum Tolerated Dose (MTD) of Lenalidomide
Time frame: after 1 cycle (each cycle is 21 days)
MTD was determined by testing planned increasing doses up to 25 mg daily dose on days 1-14, starting at 10mg. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any lenalidomide-related Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) Grade 3 or 4 adverse events
Phase II: Progression-free Survival at 1 Year
Time frame: 1 year
5 secondary outcomes
The Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide
Time frame: After 2 cycles (a cycle is 21 days)
Number of Grade >=3 Adverse Events
Time frame: Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide
Best Overall Response
Time frame: 168 days
To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets
Time frame: Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)
To Determine the Impact of Treatment on Circulating Tumor Cells
Time frame: Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25052451Agarwal N, Apolo AB, Tsao CK, Lee KM, Godbold JH, Soto R, Poole A, Gimpel-Tetra K, Lowe N, Oh WK, Galsky MD. Phase Ib/II trial of gemcitabine, cisplatin, and lenalidomide as first-line therapy in patients with metastatic urothelial carcinoma. Oncologist. 2014 Sep;19(9):915-6. doi: 10.1634/theoncologist.2014-0153. Epub 2014 Jul 22.
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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.
Matthew Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide in people with Urinary Bladder Neoplasms, run by Icahn School of Medicine at Mount Sinai at 3 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 15 inclusion and 10 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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 26 Nov 2014). 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?
Maximum Tolerated Dose (MTD) of Lenalidomide (time frame: after 1 cycle (each cycle is 21 days)). 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?
On the ClinicalTrials.gov record for NCT01342172, 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 23 Apr 2019.