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Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mitchell R. Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068773

NCT ID:

NCT00021372

Start Date:

February 1996

Completion Date:

September 2006

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Kimball Medical CenterLakewood, New Jersey  08701
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Saint Mary Regional CenterLanghorne, Pennsylvania  19047
North Penn HospitalLansdale, Pennsylvania  19446-1200
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
Conemaugh Memorial HospitalJohnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602