Rebeccamycin Analog as Second-Line Therapy in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer That Relapsed After Previous First-Line Chemotherapy

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00084487
• Other study ID #: NCI-2012-02587
• Secondary ID: NCI-2012-02587NC
• Status: Terminated
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: May 7, 2014
• Start date: April 2004
• Est. completion date: April 2008

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• becatecarin
Given IV

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate Estimated as the Proportion of Responders	Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.; An exact binomial 95% confidence interval will be calculated for this proportion.	Up to 4 years	No
Primary	Progression Free Survival	Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.	Up to 4 years	No
Primary	Overall Survival	Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.	Up to 4 years	No
Secondary	Progression Free Survival	Percentage of patients that are progression free at 6 months.	6 months	No
Secondary	Overall Survival	Percentage of patients alive at 1 year	1 year	No