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

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Irinotecan hydrochloride
Cisplatin
Krestin
Sponsored by
University of Toyama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring ED-SCLC, small cell lung cancer, CPT-11, irinotecan hydrochloride, CDDP, cisplatin, PSK, Krestin

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toho University Sakura Medical CenterRecruiting
  • Hokkaido University HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Kanazawa Medical University HospitalRecruiting
  • Kinkidaigakuigakubu Nara HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • Osaka Prefectural Medical Center for Respiratory and Allergic DiseasesRecruiting
  • Kinkidaigakuigakubu Sakai Hospital
  • NHO Kinki-chuo Chest Medical CenterRecruiting
  • Osaka Medikal College HospitalRecruiting
  • Hiroshima City Hospital
  • Osaka City General HospitalRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Toyama Red Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Outcomes

Primary Outcome Measures

Overall survival rate

Secondary Outcome Measures

Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity

Full Information

First Posted
October 17, 2007
Last Updated
September 2, 2008
Sponsor
University of Toyama
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1. Study Identification

Unique Protocol Identification Number
NCT00546130
Brief Title
Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
Acronym
RNCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toyama

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
ED-SCLC, small cell lung cancer, CPT-11, irinotecan hydrochloride, CDDP, cisplatin, PSK, Krestin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
Intervention Type
Drug
Intervention Name(s)
Irinotecan hydrochloride
Other Intervention Name(s)
Irinotecan hydrochloride: CPT-11
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatin: CDDP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Krestin
Other Intervention Name(s)
Krestin: PSK
Intervention Description
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatsuhiko Kashii, MD, PhD
Phone
+81-76-434-7808
Email
tkashii@med.u-toyama.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuhiko Kashii, MD, PhD
Organizational Affiliation
Research Network for Chemotherapy of Lung Cancer
Official's Role
Study Chair
Facility Information:
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryoji Kato, MD
Phone
+81-43-462-8811
Email
ryochan@sakura.med.toho-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Ryoji Kato, MD
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Oizumi, MD
Phone
+81-11-716-1161
Email
soizumi@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Satoshi Oizumi, MD
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuo Kasahara, MD
Phone
+81-076-265-2000
Email
kasa1237@med3.m.kanazawa-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Kazuo Kasahara, MD
Facility Name
Kanazawa Medical University Hospital
City
Uchinada
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirohisa Toga, MD
Phone
+81-76-286-3511
Email
toga-h@kanazawa-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Hirohisa Toga, MD
Facility Name
Kinkidaigakuigakubu Nara Hospital
City
Ikoma
State/Province
Nara
ZIP/Postal Code
630-0293
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshio Shimizu, MD
Phone
+81-743-77-0880
Email
tshimizu@nara.med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Toshio Shimizu, MD
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshige Yoshioka, MD
Phone
+81-86-422-0210
Email
hirotin@kchnet.or.jp
First Name & Middle Initial & Last Name & Degree
Hirishige Yoshioka, MD
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomonori Hirasima, MD
Phone
+81-957-2121
Email
hirashima@opho.jp
First Name & Middle Initial & Last Name & Degree
Tomonori Hirasima, MD
Facility Name
Kinkidaigakuigakubu Sakai Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0132
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minoru Takada, MD
Phone
+81-72-299-1120
Email
m-takada@sakai.med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Minoru Takada, MD
Facility Name
NHO Kinki-chuo Chest Medical Center
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihito Kubo, MD
Phone
+81-72-252-3021
Email
a-kubo@kch.hosp.go.jp
First Name & Middle Initial & Last Name & Degree
Akihito Kubo, MD
Facility Name
Osaka Medikal College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takayasu Kurata, MD
Phone
+81-72-683-1221
Email
ctc002@poh.osaka-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Takayasu Kurata, MD
Facility Name
Hiroshima City Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuo Iwamoto, MD
Phone
+81-82-221-2291
Email
y-iwamoto@do.enjoy.ne.jp
First Name & Middle Initial & Last Name & Degree
Yasuo Iwamoto, MD
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Takeda, MD
Phone
+81-6-6929-1221
Email
kkk-take@ga2.so-net.ne.jp
First Name & Middle Initial & Last Name & Degree
Koji Takeda, MD
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Tsuboi, MD
Phone
+81-3-3342-6111
Email
mtsuboi@za2.so-net.ne.jp
First Name & Middle Initial & Last Name & Degree
Masahiro Tsuboi, MD
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatsuhiko Kashii, MD, PhD
Phone
+81-76-434-7808
Email
tkashii@med.u-toyama.ac.jp
First Name & Middle Initial & Last Name & Degree
Tatsuhiko Kashii, MD, PhD
Facility Name
Toyama Red Cross Hospital
City
Toyama
ZIP/Postal Code
930-0859
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiichi Iwase, MD
Phone
+81-76-433-2222
Email
iwasa@toyama-med.jrc.or.jp
First Name & Middle Initial & Last Name & Degree
Keiichi Iwase, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11784874
Citation
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.
Results Reference
background
PubMed Identifier
14731333
Citation
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.
Results Reference
background
PubMed Identifier
14676791
Citation
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.
Results Reference
background

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

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