Status:
COMPLETED
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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. Givin...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00287963
Start Date
February 1 2004
End Date
January 1 2010
Last Update
May 17 2018
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425