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

NCT00057837 | Completed Phase 2 Results

• 3 other identifiers: CDR0000276590U10CA021115E5501
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 79

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

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

extensive stage small cell lung cancer; Topotecan; Etoposide; Cisplatin; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

  Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

  Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

Secondary Outcomes (2)

• Duration of Response

  Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

• Overall Survival

  Assessed every 3 months for 2 years, then every 6 months for 1 years

Study Arms (2)

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

EXPERIMENTAL

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.

Biological: G-CSF; Drug: Cisplatin; Drug: Etoposide; Drug: Topotecan

PIE (Irinotecan/Cisplatin/Etoposide)

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 of each cycle.

Drug: Cisplatin; Drug: Etoposide; Drug: Irinotecan

Interventions

G-CSF 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.

Also known as: Filgrastim, Neupogen, recombinant-rnethionyl human granulocyte-colony stimulating factor, granulocyte colony-stimulating factor, r-metHuG-CSF

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

Cisplatin 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.

Also known as: Platinol®, Cis-diaminedichloroplatinum, Cis-diaminedichloroplatinum (II), diaminedichloroplatinum, cis-platinum, platinum, Platinol, Platinol-AQ, DDP, CDDP, DACP, NSC 119875

PET (Topotecan/Etoposide/Cisplatin/G-CSF); PIE (Irinotecan/Cisplatin/Etoposide)

Etoposide 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.

Also known as: VP-16, VePesid, VP-16-213, EPEG, epipodophyllotoxin, NSC # 141540

PET (Topotecan/Etoposide/Cisplatin/G-CSF); PIE (Irinotecan/Cisplatin/Etoposide)

Irinotecan DRUG

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

Also known as: Camptothecin-11, CPT-11

PIE (Irinotecan/Cisplatin/Etoposide)

Topotecan DRUG

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

Also known as: Hycamtin®, Hycamptamine, SK&F 104864-A, Topotecan Formula AS

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (79)

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60504, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Hematology & Oncology Care

Moline, Illinois, 61265, United States

Location

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

Moline, Illinois, 61265, United States

Location

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

Olympia Fields, Illinois, 60461, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Howard Community Hospital

Kokomo, Indiana, 46904, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Clarian Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Unknown Facility

Bettendorf, Iowa, 52722, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, 21921, United States

Location

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Central Pennsylvania Hematology and Medical Oncology Associates, PC

Lemoyne, Pennsylvania, 17043, United States

Location

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, 18501, United States

Location

Hematology and Oncology Associates of Northeastern Pennsylvania

Scranton, Pennsylvania, 18510, United States

Location

Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center

Upland, Pennsylvania, 19013, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Regional Cancer Center at Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; Cisplatin; Platinum; Etoposide; Podophyllotoxin; Irinotecan; Topotecan

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Lignans; Benzyl Compounds; Benzene Derivatives; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG Statistical Office

617-632-3012

Study Officials

• Joseph Aisner, MD

  Rutgers Cancer Institute of New Jersey

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: July 14, 2004
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 5, 2023
• Results First Posted: February 13, 2013

Record last verified: 2023-06

Locations

US (79)