Clinical trial NCT00546130: Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: ED-SCLC
small cell lung cancer
CPT-11
irinotecan hydrochloride
CDDP
cisplatin
PSK
Krestin
Lead sponsor: University of Toyama
Sponsor class: OTHER
First posted: 2007-10-18
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival rate
timeFrame: one year
Secondary outcomes:
measure: Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity
timeFrame: one year
Other outcomes:
Locations:
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Uchinada
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Ikoma
country: Japan
facility: Kinkidaigakuigakubu Nara Hospital
state: Nara
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Habikino
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
state: Osaka
city: Sakai
country: Japan
facility: Kinkidaigakuigakubu Sakai Hospital
state: Osaka
city: Sakai
country: Japan
facility: NHO Kinki-chuo Chest Medical Center
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medikal College Hospital
state: Osaka
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Toyama
country: Japan
facility: Toyama Red Cross Hospital
Study officials:
affiliation: Research Network for Chemotherapy of Lung Cancer
name: Tatsuhiko Kashii, MD, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1056/NEJMoa003034.
citation: 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.
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. doi: 10.1038/sj.bjc.6601456.