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

Phase 1
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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



- Determine the maximum tolerated dose of topotecan when combined with vinorelbine
ditartrate in patients with recurrent lung cancer.


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed lung cancer

- All histologic types eligible

- Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or
without radiotherapy


- 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

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to topotecan or vinorelbine ditartrate


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Andrew S. Kraft, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

January 2010

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms



Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425