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

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 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

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