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Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
topotecan hydrochloride
vinorelbine tartrate
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, combined type small cell lung cancer, intermediate type small cell lung cancer, large cell lung cancer, lymphocyte-like type small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, squamous cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed lung cancer All histologic types eligible Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS: ECOG performance status (PS) ≤ 2 Karnofsky PS ≥ 60% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Total bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.5 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No other active invasive malignancy No uncontrolled illness including, but not limited to: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia No psychiatric illness/social situation that would limit compliance with study requirements No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 2 weeks since prior radiotherapy No prior therapy with topotecan or vinorelbine ditartrate No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) Recovered from agents administered > 4 weeks earlier No other concurrent investigational agents No concurrent palliative radiotherapy No other concurrent anticancer therapies or agents No concurrent hormones or other chemotherapy except for the following: Steroids for adrenal failure Hormones for nondisease-related conditions (e.g., insulin for diabetes) Intermittent dexamethasone as an antiemetic

Sites / Locations

  • Hollings Cancer Center at Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vinorelbine + topotecan

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose

Secondary Outcome Measures

Response rate
stable disease rate
time to progression

Full Information

First Posted
February 6, 2006
Last Updated
May 14, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00287963
Brief Title
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
Official Title
A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer. Secondary Assess the response and stable disease rates and the time to disease progression among treated patients. OUTLINE: This is a dose-escalation study of topotecan. Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, combined type small cell lung cancer, intermediate type small cell lung cancer, large cell lung cancer, lymphocyte-like type small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, squamous cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vinorelbine + topotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
Cycle 1 (up to day 21)
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
while on study, at the end of each 3 week cycle
Title
stable disease rate
Time Frame
while on study, at the end of each 3 week cycle
Title
time to progression
Time Frame
from start of treatment to day of documented progression or death, whichever comes first, up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed lung cancer All histologic types eligible Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS: ECOG performance status (PS) ≤ 2 Karnofsky PS ≥ 60% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Total bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.5 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No other active invasive malignancy No uncontrolled illness including, but not limited to: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia No psychiatric illness/social situation that would limit compliance with study requirements No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 2 weeks since prior radiotherapy No prior therapy with topotecan or vinorelbine ditartrate No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) Recovered from agents administered > 4 weeks earlier No other concurrent investigational agents No concurrent palliative radiotherapy No other concurrent anticancer therapies or agents No concurrent hormones or other chemotherapy except for the following: Steroids for adrenal failure Hormones for nondisease-related conditions (e.g., insulin for diabetes) Intermittent dexamethasone as an antiemetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S. Kraft, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gustavo Leone
Organizational Affiliation
Medical University of South Carolina, Hollings Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18096059
Citation
Beldner MA, Sherman CA, Green MR, Garrett-Mayer E, Chaudhary U, Meyer ML, Kraft AS, Montero AJ. Phase I dose escalation study of vinorelbine and topotecan combination chemotherapy in patients with recurrent lung cancer. BMC Cancer. 2007 Dec 20;7:231. doi: 10.1186/1471-2407-7-231.
Results Reference
result

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Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

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