Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy
NCT ID: NCT03193788
Last Updated: 2017-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
74 participants
INTERVENTIONAL
2017-01-31
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
pemetrexed
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
Folic Acid
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Vitamin B12 Injection
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
Dexamethasone
Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
observation
observation group will be observed with best supportive care until progressive disease
No interventions assigned to this group
Interventions
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pemetrexed
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
Folic Acid
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Vitamin B12 Injection
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
Dexamethasone
Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Korean Cancer Study Group
OTHER
Asan Medical Center
OTHER
Responsible Party
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JLee
Associated Professor
Principal Investigators
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Jae-Lyun Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Hallym University Medical Center, Hallym University College of Medicine
Anyang, , South Korea
Keimyeong University Dongsan Medical Center
Daegu, , South Korea
Fatima Hospital
Daegu, , South Korea
Chungnam University Hospital
Daejeon, , South Korea
National Health Insurance Service Ilsan Hospital
Goyang, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Gil Medical Center
Incheon, , South Korea
Dong-A University Medical Center
Pusan, , South Korea
Inje University Haeundae Paik Hospital
Pusan, , South Korea
Pusan National University Hospital, Pusan National University School of Medicine
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung Ang University Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine
Seoul, , South Korea
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, , South Korea
Yonsei Cancer Center
Seoul, , South Korea
St. Vincent's Hospital, The Catholic University of Korea
Suwon, , South Korea
Uijeongbu St Mary's hospital, Catholic university of Korea
Uijeongbu-si, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Suee Lee
Role: primary
Bhum Suk Keam
Role: primary
Role: backup
References
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von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. doi: 10.1200/JCO.2000.18.17.3068.
Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O, Delgado FM, Hurteloup P, Winquist E, Morsli N, Salhi Y, Culine S, von der Maase H. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009 Sep 20;27(27):4454-61. doi: 10.1200/JCO.2008.20.5534. Epub 2009 Aug 17.
Vaughn DJ, Broome CM, Hussain M, Gutheil JC, Markowitz AB. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002 Feb 15;20(4):937-40. doi: 10.1200/JCO.2002.20.4.937.
Sweeney CJ, Roth BJ, Kabbinavar FF, Vaughn DJ, Arning M, Curiel RE, Obasaju CK, Wang Y, Nicol SJ, Kaufman DS. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006 Jul 20;24(21):3451-7. doi: 10.1200/JCO.2005.03.6699.
Galsky MD, Moshier E, Krege S, Lin CC, Hahn N, Ecke T, Sonpavde G, Pond G, Godbold J, Oh WK, Bamias A. Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy. Urol Oncol. 2014 Jan;32(1):48.e1-8. doi: 10.1016/j.urolonc.2013.07.001. Epub 2013 Sep 18.
Other Identifiers
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KCSG GU16-05
Identifier Type: -
Identifier Source: org_study_id
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