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Comparison of Two Combination...

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

Last Updated: 2023-07-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-14

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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

* To investigate the occurrence of various breast cancer resistance protein (BCRP) alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical response and toxicity.

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

* Arm I (PET): Patients receive topotecan intravenously (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 (PIE): 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.

ACTUAL ACCRUAL: A total of 140 patients were accrued for this study.

Conditions

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Extensive Stage Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PET (Topotecan/Etoposide/Cisplatin/G-CSF)

Patients receive topotecan intravenously (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.

Group Type EXPERIMENTAL

G-CSF

Intervention Type BIOLOGICAL

G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery \> 10,000 dL.

Cisplatin

Intervention Type DRUG

Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.

Etoposide

Intervention Type DRUG

Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.

Topotecan

Intervention Type DRUG

Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).

PIE (Irinotecan/Cisplatin/Etoposide)

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 of each cycle.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.

Etoposide

Intervention Type DRUG

Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.

Irinotecan

Intervention Type DRUG

50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).

Interventions

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G-CSF

G-CSF will be administered subcutaneously at a dose of 5 mcg/kg once a day starting on day 11 until WBC recovery \> 10,000 dL.

Intervention Type BIOLOGICAL

Cisplatin

Arm PET: 20 mg/m2 IV on days 8, 9 and 10 of each cycle following Etoposide. Arm PIE: 20 mg/m2 IV on days 1 and 8 of each cycle following Irinotecan.

Intervention Type DRUG

Etoposide

Arm PET: 70 mg/m2 IV over 60 minutes on days 8, 9 and 10 of each cycle. Arm PIE: 85 mg/m2 orally (divided into 2 doses, 12 hours apart) on day 3 and 10 of each cycle.

Intervention Type DRUG

Irinotecan

50 mg/m2 IV over 90 minutes on days 1 and 8 of each cycle (Arm PIE only).

Intervention Type DRUG

Topotecan

Topotecan 0.75 mg/m2 IV over 30 minutes on days 1,2 and 3 of each cycle (Arm PET only).

Intervention Type DRUG

Other Intervention Names

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Filgrastim Neupogen recombinant-rnethionyl human granulocyte-colony stimulating factor granulocyte colony-stimulating factor r-metHuG-CSF Platinol® Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II) diaminedichloroplatinum cis-platinum platinum Platinol Platinol-AQ DDP CDDP DACP NSC 119875 VP-16 VePesid VP-16-213 EPEG epipodophyllotoxin NSC # 141540 Camptothecin-11 CPT-11 Hycamtin® Hycamptamine SK&F 104864-A Topotecan Formula AS

Eligibility Criteria

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Inclusion Criteria

* Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* Disease-free for \>=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
* Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) \>=4000/mm3 and platelets \>=100,000/mm3; bilirubin \<= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) \<=2.5 x upper limit of normal if no demonstrable liver metastases or \<=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance \>=30 using the formulas in the protocol
* Age 18 and older
* Strongly advised to use an accepted and effective method of contraception
* Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy
* Those receiving erythropoietin could continue to receive it

Exclusion Criteria

* Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases
* Prior chemotherapy for this disease
* Pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Aisner, MD

Role: STUDY_CHAIR

Rutgers Cancer Institute of New Jersey

Locations

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Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Hematology & Oncology Care

Moline, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Clarian Arnett Cancer Care

Lafayette, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

South Bend, Indiana, United States

Site Status

Bettendorf, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status