Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT00021372
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
1996-02-29
2006-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and estramustine in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
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Detailed Description
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OUTLINE: Patients receive oral estramustine 2-3 times daily on days 1-3 and paclitaxel IV over 1 hour on day 2 on weeks 1-6. Treatment repeats every 8 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response continue therapy for at least 3 courses or for 1 course after achieving maximum response. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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estramustine phosphate sodium
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3\* Platelet count greater than 75,000/mm3\* \* Unless due to lymphomatous marrow involvement Hepatic: Bilirubin less than 1.5 mg/dL\* SGOT/SGPT less than 2 times normal\* \* Unless due to lymphomatous involvement Renal: Creatinine less than 2.0 mg/dL\* OR Creatinine clearance greater than 50 mL/min\* \* Unless due to lymphomatous involvement Cardiovascular: No active uncontrolled angina pectoris No New York Heart Association class II-IV heart disease No myocardial infarction within the past 6 months No history of recurrent deep venous thrombosis not associated with catheter placement Other: No other prior malignancy within the past 5 years except curatively treated cervical cancer or basal cell or squamous cell skin cancer No serious concurrent medical illness that would preclude study No active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No prior paclitaxel, docetaxel, or estramustine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mitchell R. Smith, MD, PhD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
Kimball Medical Center
Lakewood, New Jersey, United States
South Jersey Regional Cancer Center
Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, United States
Saint Mary Regional Center
Langhorne, Pennsylvania, United States
North Penn Hospital
Lansdale, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Countries
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Other Identifiers
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FCCC-96026
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1986
Identifier Type: -
Identifier Source: secondary_id
CDR0000068773
Identifier Type: -
Identifier Source: org_study_id
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