Clinical Trial: Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Fox Chase Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Paclitaxel and Estramustine in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: February 1996

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

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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005