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

NCT00084487 | Terminated Phase 2 Results

• 8 other identifiers: NCI-2012-02587NCI-1990CASE-1503CDR0000365315CASE-CWRU-15031990U01CA062502P30CA043703
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Overall Survival

  Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.

  Up to 4 years

Secondary Outcomes (2)

• Progression Free Survival

  6 months

• Overall Survival

  1 year

Study Arms (1)

Treatment (becatecarin)

EXPERIMENTAL

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.

Drug: becatecarin

Interventions

becatecarin DRUG

Given IV

Also known as: BMS-181176, rebeccamycin analogue, rebeccamycin analogue, tartrate salt, XL119

Treatment (becatecarin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

becatecarin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Afshin Dowlati MD
• Organization: Case Comprehensive Cancer Center

afshin.dowlati@uhhospitals.org

216-844-1228

Study Officials

• Afshin Dowlati

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 23, 2014
• Results First Posted: January 1, 2014

Record last verified: 2013-01

Locations

US (1)