Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057837

Purpose

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 II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Biological: filgrastim Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Drug: topotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Irinotecan U 101440E Etoposide phosphate Topotecan hydrochloride Filgrastim Topotecan Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	March 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive topotecan IV over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.	Biological: filgrastim Given subcutaneously Drug: cisplatin Given IV Drug: etoposide Given IV (arm I) or orally (arm II) Drug: topotecan hydrochloride Given IV
Arm II: Experimental Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.	Drug: cisplatin Given IV Drug: etoposide Given IV (arm I) or orally (arm II) Drug: irinotecan hydrochloride Given IV

Detailed Description:

OBJECTIVES:

Primary

Evaluate the response frequency of patients with extensive stage small cell lung cancer treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and etoposide.
Evaluate the toxic effects of these regimens in these patients.
Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

Correlate the occurrence of various BRCP polymorphisms with clinical response and toxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive topotecan IV over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
Arm II: Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60-140 patients (30-70 per treatment arm) will be accrued for this study within 7-16 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of extensive stage small cell lung cancer
Measurable disease
CNS metastases allowed if previously treated and with no advancing symptoms

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

Creatinine clearance at least 30 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent epoetin alfa allowed provided treatment was initiated before study entry

Chemotherapy

No prior chemotherapy for this disease

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for lung cancer
Prior radiotherapy for brain metastases allowed

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057837

Show 82 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Joseph Aisner, MD	Cancer Institute of New Jersey
Investigator:	Eric H. Rubin, MD	Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	ECOG Group Chair's Office ( Robert L. Comis )
Study ID Numbers:	CDR0000276590, ECOG-5501
Study First Received:	April 7, 2003
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00057837 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Irinotecan
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Camptothecin
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Topotecan
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009