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Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
paclitaxel
topotecan hydrochloride
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000) Histologically or cytologically confirmed recurrent or refractory small cell lung cancer Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable) No mixed histology Measurable or evaluable disease that has not been in the field of prior radiotherapy No uncontrolled CNS metastases (treated CNS metastases eligible) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR Direct bilirubin normal Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina pectoris No uncontrolled congestive heart failure No myocardial infarction within the past 3 months Other: No uncontrolled infections No other concurrent malignancy except skin cancer or localized prostate cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel) At least 3 months since other prior chemotherapy Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 3 weeks since any prior major surgery

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Health Plaza
  • CCOP - Missouri Valley Cancer Consortium
  • Medcenter One Health System
  • Altru Health Systems
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Geisinger Clinic and Medical Center
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium
  • Allan Blair Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

topotecan + paclitaxel + radiotherapy

Arm Description

Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study.

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

survival

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003281
Brief Title
Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Official Title
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer. Determine the response rate and survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000. Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topotecan + paclitaxel + radiotherapy
Arm Type
Experimental
Arm Description
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
response rate
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000) Histologically or cytologically confirmed recurrent or refractory small cell lung cancer Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable) No mixed histology Measurable or evaluable disease that has not been in the field of prior radiotherapy No uncontrolled CNS metastases (treated CNS metastases eligible) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR Direct bilirubin normal Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina pectoris No uncontrolled congestive heart failure No myocardial infarction within the past 3 months Other: No uncontrolled infections No other concurrent malignancy except skin cancer or localized prostate cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel) At least 3 months since other prior chemotherapy Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 3 weeks since any prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. Jett, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Health Plaza
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Medcenter One Health System
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Altru Health Systems
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17409859
Citation
Dy GK, Jett JR, Geoffroy FJ, Krewer KD, Tazelaar H, Maurer M, Rowland K, Mailliard J, Krook J, Dakhil S, Kutteh L, Kugler J, Wender D. Topotecan and paclitaxel in previously treated patients with relapsed small cell lung cancer: phase II trial of the North Central Cancer Treatment Group. J Thorac Oncol. 2006 Mar;1(3):211-7. doi: 10.1016/s1556-0864(15)31570-7. No abstract available.
Results Reference
result

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Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

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