Topotecan, Paclitaxel, and Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

NCT ID: NCT00004055

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2004-07-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.

Detailed Description

OBJECTIVES: I. Evaluate oral topotecan and paclitaxel in terms of toxicity and complete and partial response rate in patients with previously untreated extensive stage small cell lung cancer. II. Determine preliminary estimates of survival in this patient population in response to this regimen.

OUTLINE: Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

topotecan + paclitaxel + filgrastim

Patients receive oral topotecan on days 1-5 followed by paclitaxel IV over 3 hours on day 5. Beginning 24-48 hours after chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily for up to 10 days until blood counts recover. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression. Patients who develop CNS progressive disease only should receive whole brain radiotherapy before continuing study treatment.

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Interventions

filgrastim

Intervention Type: BIOLOGICAL

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated small cell lung cancer No mixed histology Extensive disease Metastatic disease outside the chest Contralateral supraclavicular nodes or contralateral hilar nodes outside a single radiation port OR Cytologically proven malignant pleural effusion Measurable or evaluable disease No untreated CNS metastases CNS metastases previously treated with whole brain radiotherapy allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Total bilirubin no greater than 1.5 times ULN OR Direct bilirubin normal Renal: Creatinine no greater than ULN OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled angina pectoris No congestive heart failure within the past 3 months, unless ejection fraction greater than 40% No uncontrolled arrhythmias No myocardial infarction within the past 3 months Other: No significant infection No hypersensitivity to E. coli derivatives No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 10 years since prior chemotherapy No prior nitrosourea based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 10 years since prior thoracic radiotherapy No more than 3 fractions of prior thoracic radiotherapy for superior vena cava syndrome Prior palliative radiotherapy except to the chest allowed No prior radiotherapy to at least 20% bone marrow No concurrent radiotherapy (including thoracic), except whole brain radiotherapy for CNS progression Surgery: At least 3 weeks since prior major surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R. Jett, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

CCOP - Wichita

Wichita, Kansas, United States

CCOP - Duluth

Duluth, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CentraCare Clinic

Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Altru Health Systems

Grand Forks, North Dakota, United States

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

Countries

United States

References

Foster NR, Qi Y, Shi Q, Krook JE, Kugler JW, Jett JR, Molina JR, Schild SE, Adjei AA, Mandrekar SJ. Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials. Cancer. 2011 Mar 15;117(6):1262-71. doi: 10.1002/cncr.25526. Epub 2010 Oct 19.

Reference Type: BACKGROUND

PMID: 20960500 (View on PubMed)

Molina JR, Jett JR, Foster N, Lair BS, Carroll TJ, Tazelaar HD, Hillman S, Mailliard JA, Bernath AM Jr, Nikcevich D. Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer. Am J Clin Oncol. 2006 Jun;29(3):246-51. doi: 10.1097/01.coc.0000217566.11742.b5.

Reference Type: RESULT

PMID: 16755177 (View on PubMed)

Jett JR, Bernath AM Jr, Hillman SL, et al.: Oral topotecan and paclitaxel with G-CSF support in patients with untreated extensive stage small cell (ED-SCLC): a phase II trial of the NCCTG. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1301, 2002.

Reference Type: RESULT

Other Identifiers

CDR0000067251

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-982052

Identifier Type: -

Identifier Source: org_study_id