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

Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00546130
• Other study ID #: RNCLC-01
• Status: Recruiting
• Phase: Phase 2
• First received: October 17, 2007
• Last updated: September 2, 2008
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: August 2008
• Source: University of Toyama
• Contact: Tatsuhiko Kashii, MD, PhD
• Phone: +81-76-434-7808
• Email: tkashii[@]med.u-toyama.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
Japan	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Habikino	Osaka
Japan	Hiroshima City Hospital	Hiroshima
Japan	Kinkidaigakuigakubu Nara Hospital	Ikoma	Nara
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Osaka City General Hospital	Osaka
Japan	Kinkidaigakuigakubu Sakai Hospital	Sakai	Osaka
Japan	NHO Kinki-chuo Chest Medical Center	Sakai	Osaka
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Osaka Medikal College Hospital	Takatsuki	Osaka
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Toyama Red Cross Hospital	Toyama
Japan	Toyama University Hospital	Toyama
Japan	Kanazawa Medical University Hospital	Uchinada	Ishikawa

Sponsors (1)

Lead Sponsor	Collaborator
University of Toyama

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		one year	No
Secondary	Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity		one year	Yes