Urothelial CarcinomaPhase 2PECULIARNCT01490437
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
A Phase 2 study testing Pemetrexed, Cisplatin and Dexamethasone in people with Urothelial Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Pemetrexed, Cisplatin and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Dec 2013
- 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
- Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
- Patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
- Measurable disease defined by RECIST v.1.0
- ECOG performance status of 2 or better
- Adequate organ and bone marrow function defined as
Who cannot join
- Other tumor type than urothelial carcinoma
- Presence or history of CNS metastasis
- Prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
- Presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Peripheral sensory neuropathy grade 2 or worse
- Other serious illness or medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).
Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.
This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.
- Conditions
- Urothelial Carcinoma
- Being tested
- Pemetrexed, Cisplatin, Dexamethasone, Vitamins
- Keywords
- Advanced urothelial carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta
Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks
CisplatinDrug
Also called cisplan
Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days
DexamethasoneDrug
Also called Dexa
Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks
VitaminsDrug
Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7
| Study group | Role | What they receive |
|---|---|---|
| PemCis | Experimental | Pemetrexed plus Cisplatin Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Dexamethasone; Drug: Vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Based on RECIST v.1.0
Measured: 12 months
Secondary outcomes (3)
Progression-free survival
Measured: 12 months
Overall survival
Measured: 12 months
Safety
Based on NCI CTCAE v.3.0
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJul 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JLee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490437
- Sponsor's protocol ID
- UOSG-AMC-0804
- Acronym
- PECULIAR
- Status last verified
- Sep 2014
- First submitted
- 6 Dec 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi YJ, Lee SH, Lee JL, Ahn JH, Lee KH, You D, Hong B, Hong JH, Ahn H. Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17). Br J Cancer. 2015 Jan 20;112(2):260-5. doi: 10.1038/bjc.2014.591. Epub 2014 Nov 27.
PubMed 25429526
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
- ClinicalTrials.gov ID
- NCT01490437
- Acronym / sponsor ID
- PECULIAR / UOSG-AMC-0804
- Conditions
- Urothelial Carcinoma
- Keywords
- Advanced urothelial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Dec 2011 (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.
Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).
Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.
This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PemCis | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Drug: Dexamethasone, Drug: VitaminsPemetrexed plus Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
- Patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
- Measurable disease defined by RECIST v.1.0
- ECOG performance status of 2 or better
- Adequate organ and bone marrow function defined as
Key exclusion criteria (6 listed)
- Other tumor type than urothelial carcinoma
- Presence or history of CNS metastasis
- Prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
- Presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Peripheral sensory neuropathy grade 2 or worse
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 |
|---|---|---|
| PemetrexedAlso: AlimtaPemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks | Drug | PemCis |
| CisplatinAlso: cisplanCisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days | Drug | PemCis |
| DexamethasoneAlso: DexaDexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks | Drug | PemCis |
| VitaminsFolic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7 | Drug | PemCis |
Primary outcome
Response rate
Time frame: 12 months
Based on RECIST v.1.0
3 secondary outcomes
Progression-free survival
Time frame: 12 months
Overall survival
Time frame: 12 months
Safety
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Derived from this study: PubMed 25429526Choi YJ, Lee SH, Lee JL, Ahn JH, Lee KH, You D, Hong B, Hong JH, Ahn H. Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17). Br J Cancer. 2015 Jan 20;112(2):260-5. doi: 10.1038/bjc.2014.591. Epub 2014 Nov 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pemetrexed, Cisplatin and Dexamethasone in people with Urothelial Carcinoma, run by Asan Medical Center at 1 site in South Korea.
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 6 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 Sep 2014. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate (time frame: 12 months). 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 NCT01490437, 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 Sep 2014.