Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

NCT00984542 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC THO 0920P30CA068485VU-VICC-THO-0920
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

  On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)

Secondary Outcomes (4)

• Number of Patients With Each Worst-grade Toxicity

  Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days

• Best Response

  On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)

• Progression-free Survival

  On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)

• Overall Survival

  On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months

Study Arms (1)

Bendamustine

EXPERIMENTAL

Drug: bendamustine hydrochloride

Interventions

bendamustine hydrochloride DRUG

Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle

Bendamustine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Relapsed or refractory disease after 1-2 prior chemotherapy regimens * Measurable disease * ECOG - Eastern Cooperative Oncology Group performance status 0-2 * ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin normal * AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST) * Creatinine clearance \> 40 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy * No known hypersensitivity to bendamustine * No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix * No cardiac disease, including any of the following: * Unstable angina pectoris * Life-threatening cardiac arrhythmia * Symptomatic congestive heart failure * No uncontrolled infection * No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Hardin Memorial Hosptial

Elizabethtown, Kentucky, 42701, United States

Location

The Jones Clinic - Germantown

Germantown, Tennessee, 38138, United States

Location

Jackson-Madison County Hospital

Jackson, Tennessee, 38301, United States

Location

Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, 37901, United States

Location

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Leora Horn, MD
• Organization: Vanderbilt-Ingram Cancer Center

leora.horn@vanderbilt.edu

615-936-2033

Study Officials

• Leora Horn, M.D.

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2013-08

Locations

US (6)