NCT00041015

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have 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
4

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

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

September 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

July 8, 2002

Last Update Submit

January 8, 2014

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancerrecurrent small cell lung cancer

Study Arms (2)

oral topotecan plus cisplatin IV

ACTIVE COMPARATOR

oral topotecan once daily on days 1-5 and cisplatin IV on day 5

Drug: cisplatinDrug: topotecan hydrochloride

Cisplatin IV plus etoposide IV

EXPERIMENTAL

Cisplatin IV on day 1 and etoposide IV over at least 30 minutes

Drug: cisplatinDrug: etoposide

Interventions

cisplatinDRUG
Cisplatin IV plus etoposide IVoral topotecan plus cisplatin IV
etoposideDRUG
Cisplatin IV plus etoposide IV
topotecan hydrochlorideDRUG
oral topotecan plus cisplatin IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung carcinoma (SCLC) * No prior chemotherapy for SCLC OR * No chemotherapy within 5 years of diagnosis of SCLC * Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing * No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI * Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 9.0 g/dL * WBC at least 3,500/mm3 * Platelet count at least 100,000/mm3 * Neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No pre-existing renal impairment that would preclude cisplatin use Gastrointestinal: * No clinical evidence of any gastrointestinal (GI) conditions including: * Removal of a portion of the stomach * History of recent obstruction of the GI tract * GI autonomic neuropathy * Ulcerative colitis * Crohn's disease * Malabsorption syndrome * Treatment with cyclosporine that would alter absorption or GI motility * No other conditions that would preclude absorption of oral topotecan Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study * No active infection * No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer * No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance * No prior allergic reactions to compounds chemically related to study drugs * No pre-existing hearing impairment that would preclude cisplatin use * No overall medical condition for which study drugs would be inappropriate PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy for SCLC Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy for SCLC Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy for SCLC Radiotherapy: * See Disease Characteristics * At least 24 hours since prior radiotherapy with no expected bone marrow suppression * Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium) * No concurrent radiotherapy for SCLC * No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator Surgery: * At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient) Other: * More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs * No other concurrent investigational therapy for SCLC * No concurrent cyclosporine * No concurrent drugs that would preclude absorption of oral topotecan

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

CisplatinEtoposideTopotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Nathan Levitan, MD

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

September 1, 2001

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)