Clinical trial NCT00021372: Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official title: Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center
state: New Jersey
city: Lakewood
country: United States
facility: Kimball Medical Center
state: New Jersey
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center - Booker Cancer Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Altoona
country: United States
facility: Bon Secours-Holy Family Health System
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: Saint Mary Regional Center
state: Pennsylvania
city: Lansdale
country: United States
facility: North Penn Hospital
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Regional Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Mitchell R. Smith, MD, PhD
role: STUDY_CHAIR
References: