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Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

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Trial Information

Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer


OBJECTIVES:

I. Determine the objective response rate in patients with limited or extensive stage small
cell lung cancer that relapsed after prior first-line chemotherapy when treated with
rebeccamycin analogue as second-line therapy.

II. Determine the duration of remission and survival of patients treated with this drug.

III. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every
21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15
months.


Inclusion Criteria:



- Diagnosis of small cell lung cancer (SCLC)

- Limited or extensive stage

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan

- Sensitive* relapsed disease after only 1 prior chemotherapy regimen

- Brain metastasis allowed provided the following criteria are met:

- Stable brain disease

- Not receiving irradiation

- No steroid requirement to control symptoms

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- At least 12 weeks

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement
is present)

- Bilirubin ≤ 1.5 mg/dL

- Creatinine < 2.0 mg/dL

- Creatinine clearance ≥ 60 mL/min

- No New York Heart Association class III or IV heart disease

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active or ongoing infection

- No other concurrent uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- See Disease Characteristics

- See Disease Characteristics

- See Disease Characteristics

- Prior radiotherapy allowed

- No other concurrent investigational agents

- No other concurrent therapies for SCLC

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate estimated as the proportion of responders

Outcome Description:

An exact binomial 95% confidence interval will be calculated for this proportion.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Afshin Dowlati

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02587

NCT ID:

NCT00084487

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Limited Stage Small Cell Lung Cancer
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Case Western Reserve University Cleveland, Ohio  44106