NCT00087048

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

July 8, 2004

Last Update Submit

March 21, 2016

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • Safety and toxic effects

  • Recurrence-free survival

  • Time to response and tumor response

  • Quality of life

Interventions

topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer (SCLC) * Recurrent extensive stage disease * No mixed histology * Measurable disease * At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI * Sensitive disease * Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy) * Eligible for high-dose chemotherapy * No symptomatic brain metastases affecting performance status PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Hematocrit \> 35% (without transfusion) Hepatic * Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal\* * Alkaline phosphatase ≤ 2 times normal\* * Bilirubin ≤ 2.0 mg/dL * Albumin \> 2.5 g/dL * Hepatitis B surface antigen negative * No significant hepatic disease Note: \*≤ 5 times upper limit of normal if liver metastases are present Renal * Creatinine clearance ≥ 40 mL/min Cardiovascular * No history of cardiac arrhythmias * No congestive heart failure * No ischemic heart disease * No stroke or other embolic disease requiring daily treatment that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No known seizure disorder * No active infection requiring systemic therapy within the past 2 weeks * No known hypersensitivity to topotecan hydrochloride * No medical or psychiatric condition that would preclude study participation * No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy * No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC * No prior topotecan hydrochloride Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 2 months since prior investigational agent * No other concurrent investigational agent

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

Sponsors & Collaborators

Study Sites (2)

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Afshin Dowlati, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

April 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

US(2)