Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer - Full Text View

Sponsored by:	University of Toyama
Information provided by:	University of Toyama
ClinicalTrials.gov Identifier:	NCT00546130

Purpose

The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: Irinotecan hydrochloride Drug: Cisplatin Drug: Krestin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Krestin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Feasibility Study for Multicenter Randomized Controlled Phase III Clinical Trial of Cisplatin + Irinotecan Therapy and Cisplatin + Irinotecan + Krestin Therapy for Extensive-Stage Disease (ED) Small Cell Lung Cancer

Further study details as provided by University of Toyama:

Primary Outcome Measures:

Overall survival rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Irinotecan hydrochloride + Cisplatin + Krestin Therapy	Drug: 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. Drug: 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. Drug: Krestin Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.

Arms

Assigned Interventions

1: Experimental

Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Drug: 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.

Drug: 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.

Drug: Krestin

Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.

Detailed Description:

To examine whether the following protocol and regimen is appropriate for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer: set test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation, evaluate the efficacy and safety of treatment in a small number of cases, and compare with historical control or community control.

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically or cytologically proven small cell lung cancer
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 serious infection and other serious complications (including gastrointestinal bleeding and diarrhea)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546130

Contacts

Contact: Tatsuhiko Kashii, MD, PhD

+81-76-434-7808

tkashii@med.u-toyama.ac.jp

Locations

Japan
Hiroshima City Hospital	Not yet recruiting
Hiroshima, Japan, 730-8518
Contact: Yasuo Iwamoto, MD +81-82-221-2291 y-iwamoto@do.enjoy.ne.jp
Principal Investigator: Yasuo Iwamoto, MD
Osaka City General Hospital	Recruiting
Osaka, Japan, 534-0021
Contact: Koji Takeda, MD +81-6-6929-1221 kkk-take@ga2.so-net.ne.jp
Principal Investigator: Koji Takeda, MD
Tokyo Medical University Hospital	Recruiting
Tokyo, Japan, 160-0023
Contact: Masahiro Tsuboi, MD +81-3-3342-6111 mtsuboi@za2.so-net.ne.jp
Principal Investigator: Masahiro Tsuboi, MD
Toyama University Hospital	Recruiting
Toyama, Japan, 930-0194
Contact: Tatsuhiko Kashii, MD, PhD +81-76-434-7808 tkashii@med.u-toyama.ac.jp
Principal Investigator: Tatsuhiko Kashii, MD, PhD
Toyama Red Cross Hospital	Recruiting
Toyama, Japan, 930-0859
Contact: Keiichi Iwase, MD +81-76-433-2222 iwasa@toyama-med.jrc.or.jp
Principal Investigator: Keiichi Iwase, MD
Japan, Chiba
Toho University Sakura Medical Center	Recruiting
Sakura, Chiba, Japan, 285-8741
Contact: Ryoji Kato, MD +81-43-462-8811 ryochan@sakura.med.toho-u.ac.jp
Principal Investigator: Ryoji Kato, MD
Japan, Hokkaido
Hokkaido University Hospital	Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Satoshi Oizumi, MD +81-11-716-1161 soizumi@med.hokudai.ac.jp
Principal Investigator: Satoshi Oizumi, MD
Japan, Ishikawa
Kanazawa University Hospital	Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Contact: Kazuo Kasahara, MD +81-076-265-2000 kasa1237@med3.m.kanazawa-u.ac.jp
Principal Investigator: Kazuo Kasahara, MD
Kanazawa Medical University Hospital	Recruiting
Uchinada, Ishikawa, Japan, 920-0293
Contact: Hirohisa Toga, MD +81-76-286-3511 toga-h@kanazawa-med.ac.jp
Principal Investigator: Hirohisa Toga, MD
Japan, Nara
Kinkidaigakuigakubu Nara Hospital	Recruiting
Ikoma, Nara, Japan, 630-0293
Contact: Toshio Shimizu, MD +81-743-77-0880 tshimizu@nara.med.kindai.ac.jp
Principal Investigator: Toshio Shimizu, MD
Japan, Okayama
Kurashiki Central Hospital	Recruiting
Kurashiki, Okayama, Japan, 710-8602
Contact: Hiroshige Yoshioka, MD +81-86-422-0210 hirotin@kchnet.or.jp
Principal Investigator: Hirishige Yoshioka, MD
Japan, Osaka
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Recruiting
Habikino, Osaka, Japan, 583-8588
Contact: Tomonori Hirasima, MD +81-957-2121 hirashima@opho.jp
Principal Investigator: Tomonori Hirasima, MD
NHO Kinki-chuo Chest Medical Center	Recruiting
Sakai, Osaka, Japan, 591-8555
Contact: Akihito Kubo, MD +81-72-252-3021 a-kubo@kch.hosp.go.jp
Principal Investigator: Akihito Kubo, MD
Kinkidaigakuigakubu Sakai Hospital	Not yet recruiting
Sakai, Osaka, Japan, 590-0132
Contact: Minoru Takada, MD +81-72-299-1120 m-takada@sakai.med.kindai.ac.jp
Principal Investigator: Minoru Takada, MD
Osaka Medikal College Hospital	Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Takayasu Kurata, MD +81-72-683-1221 ctc002@poh.osaka-med.ac.jp
Principal Investigator: Takayasu Kurata, MD

Sponsors and Collaborators

University of Toyama

Investigators

Study Chair:

Tatsuhiko Kashii, MD, PhD

Research Network for Chemotherapy of Lung Cancer

More Information

Publications:

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.

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. Review.

Responsible Party:	Toyama University Hospital ( Tatsuhiko Kashii, MD, PhD, Associate Professor )
Study ID Numbers:	RNCLC-01
Study First Received:	October 17, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00546130
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Toyama:

ED-SCLC
small cell lung cancer
CPT-11
irinotecan hydrochloride

CDDP
cisplatin
PSK
Krestin

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Interferons
Irinotecan
Camptothecin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
PS-K
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Interferon Inducers
Anti-Infective Agents
Respiratory Tract Neoplasms
Radiation-Protective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic

Enzyme Inhibitors
Antibiotics, Antineoplastic
Protective Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009