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

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ClinicalTrials.gov Identifier: NCT03193788
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Korean Cancer Study Group
Information provided by (Responsible Party):
JLee, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Ureter Cancer Transitional Cell Carcinoma Drug: pemetrexed Drug: Folic Acid Drug: Vitamin B12 Injection Drug: Dexamethasone Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: pemetrexed maintenance

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

Drug: pemetrexed
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
Other Name: Alimta

Drug: Folic Acid
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Other Names:
  • Folvite
  • FA-8
  • FaLessa

Drug: Vitamin B12 Injection
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
Other Name: Vitabee 12

Drug: Dexamethasone
Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
Other Name: decadron

No Intervention: observation
observation group will be observed with best supportive care until progressive disease



Primary Outcome Measures :
  1. progression free survival [ Time Frame: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months ]
    Time between randomization and disease progression or death from any causes, whichever came first. Alive patients free of progression will be censored at the last follow-up


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: every 9 weeks, assess the best overall response from date of randomization until the date of first documented progression upto 24 months ]
    Objective response rate will be measured according to RECIST 1.1

  2. Incidence of treatment-emergent adverse events [ Time Frame: every 3 weeks for pemetrexed group, every 9 weeks for observation group from date of randomization until the date of first documented progression upto 24 months ]
    Safety assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03

  3. overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 1 year after the end of treatment ]
    Time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off

  4. Quality of Life [ Time Frame: before randomization, then 9, 18, and 27 weeks after randomization ]
    QoL will be assessed by EORTC QLQ-C30 core questionaire



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193788


Contacts
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Contact: Jae-Lyun Lee, MD, PhD 82 2 3010 5977 jaelyun@amc.seoul.kr
Contact: MiRan Kim 82 2 3010 5576 crnonc12@amc.seoul.kr

Locations
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Korea, Republic of
Hallym University Medical Center, Hallym University College of Medicine Recruiting
Anyang, Korea, Republic of
Contact: Ho Young Kim       ksfam@daum.net   
Keimyeong University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Jin Young Kim, MD       takgu@dsmc.or.kr   
Fatima Hospital Recruiting
Daegu, Korea, Republic of
Contact: Jung Lim Lee       junglim3@gmail.com   
Chungnam University Hospital Recruiting
Daejeon, Korea, Republic of, 301-721
Contact: Hyo Jin Lee, MD, PhD.       cymed@cnu.ac.kr   
National Health Insurance Service Ilsan Hospital Recruiting
Goyang, Korea, Republic of
Contact: Soo Jung Hong       suzzy901@nhimc.or.kr   
Hallym University Dongtan Sacred Heart Hospital Recruiting
Hwaseong-si, Korea, Republic of
Contact: Hyun Ae Jung       hyunaejung@hallym.or.kr   
Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Contact: Inkeun Park, MD       ingni79@hanmail.net   
Dong-A University Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Suee Lee         
Inje University Haeundae Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Il-Hwan Kim       onelement@daum.net   
Pusan National University Hospital, Pusan National University School of Medicine Recruiting
Pusan, Korea, Republic of
Contact: Hyo Jung Kim       leonkim80@naver.com   
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jae-Lyun Lee, MD, PhD    82 2 3010 5977    jaelyun@amc.seoul.kr   
Chung Ang University Hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Hee Joon Kim, MD       heejun.dino11@gmail.com   
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byeong Seok Sohn       imbs@paik.ac.kr   
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Yun-Gyoo Lee       gosciny@gmail.com   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yoon Ji Choi       yoonji23@hanmail.net   
Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Bhum Suk Keam         
Contact       bhumsuk@snu.ac.kr   
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of
Contact: In-Ho Kim       ihkmd@naver.com   
Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of
Contact: Sang Joon Shin       ssj338@yuhs.ac   
St. Vincent's Hospital, The Catholic University of Korea Recruiting
Suwon, Korea, Republic of
Contact: Byoung Yong Shim       shimby@catholic.ac.kr   
Uijeongbu St Mary's hospital, Catholic university of Korea Recruiting
Uijeongbu, Korea, Republic of
Contact: Yoon Ho Ko       koyoonho@catholic.ac.kr   
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Kwonoh Park       parkkoh@hanmail.net   
Sponsors and Collaborators
Asan Medical Center
Korean Cancer Study Group
Investigators
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Principal Investigator: Jae-Lyun Lee, MD, PhD Asan Medical Center

Publications of Results:

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Responsible Party: JLee, Associated Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03193788     History of Changes
Other Study ID Numbers: KCSG GU16-05
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Ureteral Diseases
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Dexamethasone
Dexamethasone acetate
Pemetrexed
BB 1101
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents