Brief Title
Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy
Official Title
A Prospective Randomized Phase III Trial of Maintenance Pemetrexed Versus Observation in Patients With Recurrent or Metastatic Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy Without Disease Progression
Brief Summary
This study aims to verify superiority of pemetrexed maintenance to observation for patient
without disease progression after 1 st line cisplatin-based chemotherapy.
Detailed Description
Patients with unresectable locally advanced, recurrent, or metastatic urothelial carcinoma of
bladder, ureter, or renal pelvis who do not experience disease progression after 4 to 6
cycles of 1 st line chemotherapy administration.
After completion of 4-6 cycles, patients without disease progression on CT which is taken
within 3 weeks after administration of the last chemotherapy will be randomized within 4
weeks after administration of the last chemotherapy to assign either maintenance group or
observation group.
Pemetrexed 500 mg/m 2 mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of
each 21 day cycle, with vitamin supplementation (folic acid 1000μg daily orally from 7 days
prior to treatment initiation and vitamin B12 1000 μg IM 7 days prior to treatment initiation
and then every 3 cycles). Thereafter, vitamin B12 can be injected on the same day of
pemetrexed infusion. Dexamethasone 4 mg orally twice daily for 3 days beginning the day
before treatment to minimize cutaneous reactions.
Treatment continues until occurrence of disease progression or intolerable toxicities upto
maximum of 16 cycles.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
progression free survival
Secondary Outcome
objective response rate
Condition
Bladder Cancer
Intervention
pemetrexed
Study Arms / Comparison Groups
pemetrexed maintenance
Description: Drug: Pemetrexed Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation. Drug: folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment Drug: vitamin B12 injection 1000 μg IM 7 days prior to treatment initiation and the every then every 3 cycles until the end of treatment Drug: dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
74
Start Date
January 2017
Completion Date
June 2020
Primary Completion Date
December 2019
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically confirmation urothelial cancer of bladder, ureter, or
renal pelvis.
2. Patients must present with locally advanced, recurrent or metastatic disease not
amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
3. Patients who were administered 4-6 cycles of cisplatin-based first line chemotherapy
[GP (gemcitabine/cisplatin), classic MVAC
(methotrexate/vinblastine/doxorubicin/cisplatin), or dose-dense MVAC] and were planned
to undergo regular surveillance
4. ce after confirmation of absence of disease progression on CT taken within 3 week
after the administration of the last cycle of 1st line chemotherapy.
5. For patients with recurrent disease who received prior adjuvant or neoadjuvant
chemotherapy with cisplatin-containing regimen, the last administration of previous
treatment should be administered at least 6 months before start date of 1st line
chemotherapy.
6. Measurable disease according RECIST criteria v 1.1.
7. Age 20 years or older
8. ECOG performance status 2 or better
9. Adequate bone marrow, hepatic, and renal function
10. Signed and dated informed consent of document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment
Exclusion Criteria:
1. Prior systemic chemotherapy or immunotherapy for palliative aim before or after 1st
line cisplatin-based chemotherapy. However, prior intravesical chemotherapy or
immunotherapy is allowed.
2. Disease progression during or after 1st line cisplatin-based chemotherapy
3. Known CNS metastasis
4. Diagnosis of any serious secondary malignancy within the last 2 years, except for
adequately treated basal cell or squamous cell carcinoma of skin, early gastric
carcinoma, early stage thyroid carcinoma, insignificant prostate carcinoma, or in situ
carcinoma of cervix uteri
5. Pregnancy or breast feeding.
6. Serious hypersensitivity reaction to pemetrexed.
7. Severe renal function impairment with creatinine clearance <45 mL/min by standard
Cockcroft-Gault formula or GFR measured by Tc99m-DPTA serum clearance method.
8. Other severe acute or chronic medical or psychiatric condition
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jae-Lyun Lee, MD, PhD, 82 2 3010 5977, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03193788
Organization ID
KCSG GU16-05
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Korean Cancer Study Group
Study Sponsor
Jae-Lyun Lee, MD, PhD, Principal Investigator, Asan Medical Center
Verification Date
May 2017