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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000001733 |
Receipt No. | R000002085 |
Scientific Title | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study |
Date of disclosure of the study information | 2009/02/26 |
Last modified on | 2016/03/28 |
Basic information | ||
Public title | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study | |
Acronym | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study | |
Scientific Title | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study | |
Scientific Title:Acronym | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study | |
Region |
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Condition | ||
Condition | Lung Cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study was to analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD. |
Basic objectives2 | Pharmacokinetics |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | To analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD. |
Key secondary outcomes | To evaluate feasibility and toxicity. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Dose comparison |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | CDDP 60 mg/m2 day-1 (0.5-h infusion)
CPT-11 30 to 60 mg/m2 day-1, 8, 15 (1.5-h infusion) HD was started immediately after completing the administration of CPT-11, and the chemotherapy was repeated every 4 weeks. The dose of CPT-11 was escalated by 10mg/m2 increment course-by-course within every patient. |
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Interventions/Control_2 | ||
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Eligibility criteria included histologically or cytologically confirmed lung cancer and renal insufficiency undergoing HD, no prior chemotherapy,life expectancy of at least 3 months, age of 20-74 years, PS of 0,1 or 2 according to the European Cooperative Oncology Group scale, the presence of measurable or evaluable disease, adequate functional indices for bone marrow leucocyte or granulocyte count >4x109/l or 2x109, PLT count100x109/l, hemoglobin concentration>9g/dl, AST ALT<100IU/l, serum bilirubin>2.0g/dl), no medical problems severe enough to prevent compliance with the protocol. | |||
Key exclusion criteria | Patients with other concurrent malignancies, active infections, pulmonary fibrosis, uncontrolled massive pleural effusion or ascites, significant cardiovascular diseases, or symptomatic metastasis to the brain, pregnancy or breast-feeding were excluded. | |||
Target sample size | 16 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Niigata University Medical and Dental Hospital | ||||||
Division name | Bioscience medical research center | ||||||
Zip code | |||||||
Address | 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520 | ||||||
TEL | 025-227-2517 | ||||||
hy0522@med.niigata-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Niigata University Medical and Dental Hospital | ||||||
Division name | Bioscience medical research center | ||||||
Zip code | |||||||
Address | 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520 | ||||||
TEL | 025-227-2517 | ||||||
Homepage URL | |||||||
hy0522@med.niigata-u.ac.jp |
Sponsor | |
Institute | Niigata Lung Cancer Treatment Group |
Institute | |
Department |
Funding Source | |
Organization | Niigata Lung Cancer Treatment Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 新潟大学医歯学総合病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Terminated | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002085 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |