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

September 2, 2008 updated by: University of Toyama

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 730-8518
        • Not yet recruiting
        • Hiroshima City Hospital
        • Contact:
        • Principal Investigator:
          • Yasuo Iwamoto, MD
      • Osaka, Japan, 534-0021
        • Recruiting
        • Osaka City General Hospital
        • Contact:
      • Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Masahiro Tsuboi, MD
      • Toyama, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital
        • Contact:
        • Principal Investigator:
          • Tatsuhiko Kashii, MD, PhD
      • Toyama, Japan, 930-0859
        • Recruiting
        • Toyama Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Keiichi Iwase, MD
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center
        • Contact:
        • Principal Investigator:
          • Ryoji Kato, MD
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
        • Principal Investigator:
          • Satoshi Oizumi, MD
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
        • Principal Investigator:
          • Kazuo Kasahara, MD
      • Uchinada, Ishikawa, Japan, 920-0293
        • Recruiting
        • Kanazawa Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Hirohisa Toga, MD
    • Nara
      • Ikoma, Nara, Japan, 630-0293
        • Recruiting
        • Kinkidaigakuigakubu Nara Hospital
        • Contact:
        • Principal Investigator:
          • Toshio Shimizu, MD
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Recruiting
        • Kurashiki Central Hospital
        • Contact:
        • Principal Investigator:
          • Hirishige Yoshioka, MD
    • Osaka
      • Habikino, Osaka, Japan, 583-8588
        • Recruiting
        • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
        • Contact:
        • Principal Investigator:
          • Tomonori Hirasima, MD
      • Sakai, Osaka, Japan, 590-0132
        • Not yet recruiting
        • Kinkidaigakuigakubu Sakai Hospital
        • Contact:
        • Principal Investigator:
          • Minoru Takada, MD
      • Sakai, Osaka, Japan, 591-8555
        • Recruiting
        • NHO Kinki-Chuo Chest Medical Center
        • Contact:
        • Principal Investigator:
          • Akihito Kubo, MD
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medikal College Hospital
        • Contact:
        • Principal Investigator:
          • Takayasu Kurata, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: one year
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
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toyama

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNCLC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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