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Home > "P" Clinical Trials Conditions > Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent mantle cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent adult lymphoblastic lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. 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.
Details: OBJECTIVES: I. Determine the response rate, time to treatment failure, and overall survival of patients with relapsed or refractory non-Hodgkin's lymphoma treated with paclitaxel and estramustine. II. Determine the toxicity of this regimen in this patient population. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed relapsed or refractory intermediate, high-grade, or transformed non-Hodgkin's lymphoma; Received 1-3 prior treatment regimens (cytoreductive chemotherapy followed by high-dose therapy with stem cell support considered 1 regimen) - Measurable disease [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MitchellSmith, Study Chair, Fox Chase Cancer Center
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Additional Information:
Study ID Numbers: CDR0000068773; NCI-G01-1986,FCCC-96026
Study Start Date: February 1996
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021372
Other Recurrent Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
2. Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer
3. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
4. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
5. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade I follicular small cleaved cell lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Lansdale Clinical Trials
Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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