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

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

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Irinotecan hydrochloride; Drug: Cisplatin; Drug: Krestin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 1; 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.; Other Names: Irinotecan hydrochloride: CPT-11; 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.; Other Names: Cisplatin: CDDP; Drug: Krestin; Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.; Other Names: Krestin: PSK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival rate	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Toyama
• Investigators: Study Chair: Tatsuhiko Kashii, MD, PhD, Research Network for Chemotherapy of Lung Cancer

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ANTICIPATED): September 1, 2011
• Study Completion (ANTICIPATED): September 1, 2011

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 17, 2007
• First Posted (ESTIMATE): October 18, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2008
• Last Update Submitted That Met QC Criteria: September 2, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: cisplatin; small cell lung cancer; CPT-11; ED-SCLC; CDDP; PSK; Krestin; irinotecan hydrochloride
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Adjuvants, Immunologic; Antibiotics, Antineoplastic; Topoisomerase I Inhibitors; Interferon Inducers; Radiation-Protective Agents; Cisplatin; Irinotecan; polysaccharide-K
• Other Study ID Numbers: RNCLC-01