Overview

Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

Status:
Unknown status
Trial end date:
2020-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Korean Cancer Study Group
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Folic Acid
Hydroxocobalamin
Pemetrexed
Vitamin B 12
Vitamin B Complex
Vitamins
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