Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00984542
First received: September 24, 2009
Last updated: July 3, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: bendamustine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC). |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Median time to progression of disease [ Time Frame: at off-treatment, up to 18 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity [ Time Frame: 30 days after completing treatment ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: at off-treatment, up to 18 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: date on study to progression-free survival ] [ Designated as safety issue: No ]
- Overall survival rate [ Time Frame: date on study to date of death from any cause ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine |
Drug: bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
|
Detailed Description:
OBJECTIVES:
Primary
- To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.
Secondary
- To determine the toxicity of this drug in these patients.
- To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-8 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Relapsed or refractory disease after 1-2 prior chemotherapy regimens
- Measurable disease
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- 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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984542
Locations
| United States, Kentucky | |
| Hardin Memorial Hosptial | |
| Elizabethtown, Kentucky, United States, 42701 | |
| United States, Tennessee | |
| The Jones Clinic - Germantown | |
| Germantown, Tennessee, United States, 38138 | |
| Jackson-Madison County Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| Baptist Regional Cancer Center at Baptist Riverside | |
| Knoxville, Tennessee, United States, 37901 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | Leora Horn, M.D. | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Leora Horn, MD, Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00984542 History of Changes |
| Other Study ID Numbers: | VICC THO 0920, P30CA068485, VU-VICC-THO-0920 |
| Study First Received: | September 24, 2009 |
| Last Updated: | July 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
recurrent small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Bendamustine Nitrogen Mustard Compounds Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013