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.

Condition	Treatment or Intervention	Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma recurrent adult diffuse mixed cell lymphoma recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma	Drug: estramustine  Drug: paclitaxel	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New Jersey
      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
      Hunterdon Regional Cancer Center, Flemington,  New Jersey,  08822,  United States
      Kimball Medical Center, Lakewood,  New Jersey,  08701,  United States
      Riverview Medical Center - Booker Cancer Center, Red Bank,  New Jersey,  07701,  United States
      South Jersey Regional Cancer Center, Millville,  New Jersey,  08332,  United States
      St. Francis Medical Center, Trenton,  New Jersey,  08629,  United States
Pennsylvania
      Bon Secours-Holy Family Health System, Altoona,  Pennsylvania,  16602,  United States
      Conemaugh Memorial Hospital, Johnstown,  Pennsylvania,  15905,  United States
      Delaware County Memorial Hospital, Drexel Hill,  Pennsylvania,  19026,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      North Penn Hospital, Lansdale,  Pennsylvania,  19446-1200,  United States
      Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States
      Pinnacle Health Hospitals, Harrisburg,  Pennsylvania,  17105-8700,  United States
      Pottstown Memorial Regional Cancer Center, Pottstown,  Pennsylvania,  19464,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      Saint Mary Regional Center, Langhorne,  Pennsylvania,  19047,  United States

Study chairs or principal investigators

Mitchell Reed Smith,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000068773; FCCC-96026; NCI-G01-1986
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021372
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08