Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
NCT ID: NCT00546130
Last Updated: 2008-09-03
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
PHASE2
45 participants
INTERVENTIONAL
2007-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
Irinotecan hydrochloride
Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
Cisplatin
Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Krestin
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Interventions
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Irinotecan hydrochloride
Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
Cisplatin
Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Krestin
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients receiving chemotherapy for the first time
* Patients with no indication for radical radiotherapy or surgical resection
* Patients diagnosed as ED\* by full staging \[chest X ray, chest C, brain CT or MRI, abdominal CT or abdominal ultrasonography, whole body bone scintigraphy (may be replaced by PET/CT)\]
* ED: Patient with distant metastasis including contralateral hilar lymph node metastasis, but ipsilateral pleural effusion without distant metastasis is excluded.
* Patients with lesions measurable or evaluable by the RECIST criteria
* Patients aged from 20 years to below 75 years
* Patients with preserved organ functions as indicated by the following test values (data obtained within 14 days prior to registration) Hemoglobin: ≥9.0 g/dL White blood cell count: ≥4,000/mm3, ≤12,000 /mm3 Neutrophil count: ≥ 2,000/mm3 Platelet count: ≥100,000 /mm3 GOT, GPT: below 2.5 times the upper limit of normal range for individual facility Total bilirubin: ≤1.5 mg/dL Serum creatinine: below the lower limit of normal range for individual facility Creatinine clearance: ≥ 60mL/min Arterial oxygen tension （PaO2）: ≥60 torr (resting)
* Performance status (PS): 0-1
* Absence of serious concurrent cardiac or pulmonary disease
* Patients expected to survive for at least 3 months
* Patients from whom written informed consent can be obtained
Exclusion Criteria
* Patients with pleural effusion, ascites, or pericardial effusion that requires treatments including puncture drainage and intracavity administration
* Patients showing definite interstitial pneumonitis or pulmonary fibrosis on plain chest radiograph
* Patients manifesting central nervous system symptoms due to brain metastasis at registration
* Patients with active multiple cancers
* Patients who had undergone bone marrow transplantation
* Patients who had undergone peripheral blood stem cell transplantation
* Patients with a history of definite drug allergy
* Pregnant and nursing patients, patients who may be pregnant or who intend to become pregnant
* Male patients with reproductive capacity who have no intention of contraception during the clinical trial
* Patients with poorly controlled diabetes
* Patients who had been administered Krestin in the past
* Others: patients who are judged by the investigator or subinvestigator to be unsuitable as subject
20 Years
74 Years
ALL
No
Sponsors
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University of Toyama
OTHER
Responsible Party
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Toyama University Hospital
Principal Investigators
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Tatsuhiko Kashii, MD, PhD
Role: STUDY_CHAIR
Research Network for Chemotherapy of Lung Cancer
Locations
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Toho University Sakura Medical Center
Sakura, Chiba, Japan
Hiroshima City Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanazawa Medical University Hospital
Mukai-awagasaki, Ishikawa-ken, Japan
Kinkidaigakuigakubu Nara Hospital
Ikoma, Nara, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, Japan
Osaka City General Hospital
Osaka, Osaka, Japan
Kinkidaigakuigakubu Sakai Hospital
Sakai, Osaka, Japan
NHO Kinki-chuo Chest Medical Center
Sakai, Osaka, Japan
Osaka Medikal College Hospital
Takatsuki, Osaka, Japan
Tokyo Medical University Hospital
Tokyo, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Toyama Red Cross Hospital
Toyama, Toyama, Japan
Countries
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Central Contacts
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Facility Contacts
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Ryoji Kato, MD
Role: primary
Yasuo Iwamoto, MD
Role: primary
Satoshi Oizumi, MD
Role: primary
Kazuo Kasahara, MD
Role: primary
Hirohisa Toga, MD
Role: primary
Toshio Shimizu, MD
Role: primary
Hiroshige Yoshioka, MD
Role: primary
Tomonori Hirasima, MD
Role: primary
Koji Takeda, MD
Role: primary
Minoru Takada, MD
Role: primary
Akihito Kubo, MD
Role: primary
Takayasu Kurata, MD
Role: primary
Masahiro Tsuboi, MD
Role: primary
Tatsuhiko Kashii, MD, PhD
Role: primary
Keiichi Iwase, MD
Role: primary
References
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Noda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N; Japan Clinical Oncology Group. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):85-91. doi: 10.1056/NEJMoa003034.
Fisher MD, D'Orazio A. Irinotecan and cisplatin versus etoposide and cisplatin in small-cell lung cancer: JCOG 9511. Clin Lung Cancer. 2000 Aug;2(1):23-4. No abstract available.
Saijo N. Progress in treatment of small-cell lung cancer: role of CPT-11. Br J Cancer. 2003 Dec 15;89(12):2178-83. doi: 10.1038/sj.bjc.6601456.
Other Identifiers
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RNCLC-01
Identifier Type: -
Identifier Source: org_study_id