Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

NCT ID: NCT00287963

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2010-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinorelbine + topotecan

Group Type: EXPERIMENTAL

topotecan hydrochloride

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

Interventions

topotecan hydrochloride

Intervention Type: DRUG

vinorelbine tartrate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S. Kraft, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18096059 (View on PubMed)

Other Identifiers

MUSC-104864/725

Identifier Type: -

Identifier Source: secondary_id

GSK-100780

Identifier Type: -

Identifier Source: secondary_id

CDR0000454919

Identifier Type: -

Identifier Source: org_study_id