Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 1

Conditions

Lung Cancer

Treatments

Drug: vinorelbine tartrate

Drug: topotecan hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00287963

GSK-100780

CDR0000454919

MUSC-104864/725

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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