Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003666|
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : July 20, 2016
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: 6-hydroxymethylacylfulvene||Phase 2|
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer|
|Study Start Date :||November 1998|
|Primary Completion Date :||September 2004|
|Study Completion Date :||January 2006|
treatment of refractory or relapsed NSCLC with HMAF
11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
Other Name: irofulven
- Response [ Time Frame: ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression ]
- Toxicity [ Time Frame: Each tx cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003666
Show 48 Study Locations
|Study Chair:||Carol A. Sherman, MD||Medical University of South Carolina|