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

Sponsor

University of Toyama (Other)

Overall Status

Unknown status

CT.gov ID

NCT00546130

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Irinotecan hydrochloride Drug: Cisplatin Drug: Krestin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival rate [one year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toho University Sakura Medical Center	Sakura	Chiba	Japan	285-8741
2	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
3	Kanazawa University Hospital	Kanazawa	Ishikawa	Japan	920-8641
4	Kanazawa Medical University Hospital	Uchinada	Ishikawa	Japan	920-0293
5	Kinkidaigakuigakubu Nara Hospital	Ikoma	Nara	Japan	630-0293
6	Kurashiki Central Hospital	Kurashiki	Okayama	Japan	710-8602
7	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Habikino	Osaka	Japan	583-8588
8	Kinkidaigakuigakubu Sakai Hospital	Sakai	Osaka	Japan	590-0132
9	NHO Kinki-chuo Chest Medical Center	Sakai	Osaka	Japan	591-8555
10	Osaka Medikal College Hospital	Takatsuki	Osaka	Japan	569-8686
11	Hiroshima City Hospital	Hiroshima		Japan	730-8518
12	Osaka City General Hospital	Osaka		Japan	534-0021
13	Tokyo Medical University Hospital	Tokyo		Japan	160-0023
14	Toyama University Hospital	Toyama		Japan	930-0194
15	Toyama Red Cross Hospital	Toyama		Japan	930-0859