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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2011

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.

Interventions

  • 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, Groups and Cohorts

  • Experimental: 1
    • Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival rate
    • Time Frame: one year

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Toyama
  • Provider of Information About this Clinical Study
    • Tatsuhiko Kashii, MD, PhD, Associate Professor, Toyama University Hospital
  • Overall Official(s)
    • Tatsuhiko Kashii, MD, PhD, Study Chair, Research Network for Chemotherapy of Lung Cancer
  • Overall Contact(s)
    • Tatsuhiko Kashii, MD, PhD, +81-76-434-7808, tkashii@med.u-toyama.ac.jp

References

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.

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