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

NCT00546130 | Unknown Phase 2 DMC

• 1 other identifier: RNCLC-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 15

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.

Conditions

Small Cell Lung Cancer

Keywords

ED-SCLC; small cell lung cancer; CPT-11; irinotecan hydrochloride; CDDP; cisplatin; PSK; Krestin

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (1)

1

EXPERIMENTAL

Irinotecan hydrochloride + Cisplatin + Krestin Therapy

Drug: Irinotecan hydrochloride; Drug: Cisplatin; Drug: Krestin

Interventions

Irinotecan hydrochloride DRUG

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.

Also known as: Irinotecan hydrochloride: CPT-11

1

Cisplatin DRUG

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.

Also known as: Cisplatin: CDDP

1

Krestin DRUG

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

Also known as: Krestin: PSK

1

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toyama: lead

Study Sites (15)

Toho University Sakura Medical Center

Sakura, Chiba, 285-8741, Japan

RECRUITING

Hiroshima City Hospital

Hiroshima, Hiroshima, 730-8518, Japan

NOT YET RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

Kanazawa Medical University Hospital

Mukai-awagasaki, Ishikawa-ken, 920-0293, Japan

RECRUITING

Kinkidaigakuigakubu Nara Hospital

Ikoma, Nara, 630-0293, Japan

RECRUITING

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

RECRUITING

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Habikino, Osaka, 583-8588, Japan

RECRUITING

Osaka City General Hospital

Osaka, Osaka, 534-0021, Japan

RECRUITING

Kinkidaigakuigakubu Sakai Hospital

Sakai, Osaka, 590-0132, Japan

NOT YET RECRUITING

NHO Kinki-chuo Chest Medical Center

Sakai, Osaka, 591-8555, Japan

RECRUITING

Osaka Medikal College Hospital

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Tokyo Medical University Hospital

Tokyo, Tokyo, 160-0023, Japan

RECRUITING

Toyama University Hospital

Toyama, Toyama, 930-0194, Japan

RECRUITING

Toyama Red Cross Hospital

Toyama, Toyama, 930-0859, Japan

RECRUITING

Related Publications (3)

• 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.

  PMID: 11784874 BACKGROUND

• 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.

  PMID: 14731333 BACKGROUND

• 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.

  PMID: 14676791 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Irinotecan; Cisplatin; DCM-Dex-CDDP; polysaccharide-K

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Tatsuhiko Kashii, MD, PhD

  Research Network for Chemotherapy of Lung Cancer

  STUDY CHAIR

Central Study Contacts

Tatsuhiko Kashii, MD, PhD

CONTACT

+81-76-434-7808; tkashii@med.u-toyama.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 3, 2008

Record last verified: 2008-08

Locations

JP (15)