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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021372
  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 Intervention Phase
Lymphoma
Drug: estramustine phosphate sodium
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Paclitaxel    Estramustine    Estramustine phosphate    Estramustine phosphate sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 1996

Detailed Description:

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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021372

Locations
United States, New Jersey
Community Medical Center    
      Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County    
      Mount Holly, New Jersey, United States, 08060
Hunterdon Regional Cancer Center    
      Flemington, New Jersey, United States, 08822
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
Riverview Medical Center - Booker Cancer Center    
      Red Bank, New Jersey, United States, 07701
South Jersey Regional Cancer Center    
      Millville, New Jersey, United States, 08332
Kimball Medical Center    
      Lakewood, New Jersey, United States, 08701
United States, Pennsylvania
Bon Secours-Holy Family Health System    
      Altoona, Pennsylvania, United States, 16602
Saint Mary Regional Center    
      Langhorne, Pennsylvania, United States, 19047
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
North Penn Hospital    
      Lansdale, Pennsylvania, United States, 19446-1200
Paoli Memorial Hospital    
      Paoli, Pennsylvania, United States, 19301-1792
Pinnacle Health Hospitals    
      Harrisburg, Pennsylvania, United States, 17105-8700
Pottstown Memorial Regional Cancer Center    
      Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052
Conemaugh Memorial Hospital    
      Johnstown, Pennsylvania, United States, 15905

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Mitchell R. Smith, MD, PhD     Fox Chase Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068773, FCCC-96026, NCI-G01-1986
First Received:   July 11, 2001
Last Updated:   October 12, 2008
ClinicalTrials.gov Identifier:   NCT00021372
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult diffuse large cell lymphoma  
recurrent adult immunoblastic large cell lymphoma  
recurrent adult lymphoblastic lymphoma  
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Estramustine
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Lymphoblastic lymphoma
Mantle cell lymphoma
Lymphoma, large-cell, immunoblastic
Recurrence
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Lymphatic Diseases
Paclitaxel
B-cell lymphomas
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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