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

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extensive Stage Small Cell Lung Cancer

Intervention: G-CSF (Biological); Cisplatin (Drug); Etoposide (Drug); Irinotecan (Drug); Topotecan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Joseph Aisner, MD, Study Chair, Affiliation: Rutgers Cancer Institute of New Jersey

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

Secondary outcome:

Duration of Response

Overall Survival

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

- 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware 19958, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Medical Center of Central Georgia, Macon, Georgia 31208, United States

Rush-Copley Cancer Care Center, Aurora, Illinois 60504, United States

Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States

Hematology & Oncology Care, Moline, Illinois 61265, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois 61265, United States

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields, Illinois 60461, United States

Swedish-American Regional Cancer Center, Rockford, Illinois 61104-2315, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Howard Community Hospital, Kokomo, Indiana 46904, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States

Clarian Arnett Cancer Care, Lafayette, Indiana 47904, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States

Bettendorf, Iowa 52722, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States

Southwest Medical Center, Liberal, Kansas 67901, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas 67203, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States

CCOP - Wichita, Wichita, Kansas 67214, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Union Hospital Cancer Program at Union Hospital, Elkton MD, Maryland 21921, United States

Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland 21701, United States

Borgess Medical Center, Kalamazoo, Michigan 49001, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States

Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States

Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey 08822, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey 08690, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey 08053, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey 08043, United States

Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey 08043, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States

Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio 44309-2090, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States

St. Rita's Medical Center, Lima, Ohio 45801, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States

Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg, Pennsylvania 18301, United States

Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne, Pennsylvania 17043, United States

Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States

Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton, Pennsylvania 18510, United States

Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania 18501, United States

Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center, Upland, Pennsylvania 19013, United States

Chester County Hospital, West Chester, Pennsylvania 19380, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

Regional Cancer Center at Sacred Heart Hospital, Eau Claire, Wisconsin 54701, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin 54868, United States

Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2004
Last updated: January 11, 2013

Page last updated: August 23, 2015

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