NCT00132054

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 lung-cancer

Timeline
Completed

Started May 2004

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2006

Enrollment Period

2.6 years

First QC Date

August 16, 2005

Last Update Submit

May 29, 2013

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Interventions

amrubicin hydrochlorideDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Extensive stage disease * Recurrent or relapsed disease after 1-2 prior chemotherapy and/or radiotherapy regimens * No unmanageable massive pleural effusion or pericardial effusion by chest CT scan * No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL Hepatic * ALT and AST ≤ 2 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine normal Cardiovascular * No uncontrolled hypertension * No unstable angina * No congestive heart failure * No myocardial infarction within the past year * No ventricular arrhythmia requiring medical intervention * No other serious cardiovascular disease Pulmonary * Arterial oxygen pressure (PaO\_2) ≥ 70 torr * No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Gastrointestinal * No serious diarrhea * No paralytic or obstructive ileus Other * Not pregnant or nursing * No uncontrolled diabetes * No severe infectious disorder PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior anthracycline or its derivatives at \> the upper dose limit (e.g., daunorubicin ≥ 25 mg/kg, doxorubicin ≥ 500 mg/m\^2, or epirubicin ≥ 900 mg/m\^2) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Gunma Cancer Center

Gunma, 373-0828, Japan

Location

National Hospital Organization - Dohoku National Hospital

Hokkaido, 070-0901, Japan

Location

Kyoto University Hospital

Kyoto, 606-8501, Japan

Location

Kitano Hospital

Osaka, 530-8480, Japan

Location

Osaka Police Hospital

Osaka, 543-0035, Japan

Location

Osaka Kosei Nenkin Hospital

Osaka, 553-0003, Japan

Location

National Hospital Organization - Osaka National Hospital

Osaka, 591-8555, Japan

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

amrubicinIrinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Tadashi Mio, MD

    Kyoto University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 19, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2006

Study Completion

November 1, 2008

Last Updated

May 30, 2013

Record last verified: 2006-12

Locations

JP(7)