Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287963
• Other study ID #: CDR0000454919
• Secondary ID: MUSC-104864/725G
• Status: Completed
• Phase: Phase 1
• Start date: February 2004
• Est. completion date: January 2010

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• topotecan hydrochloride

• vinorelbine tartrate

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		Cycle 1 (up to day 21)
Secondary	Response rate		while on study, at the end of each 3 week cycle
Secondary	stable disease rate		while on study, at the end of each 3 week cycle
Secondary	time to progression		from start of treatment to day of documented progression or death, whichever comes first, up to 36 months