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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021372 |
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 |
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Lymphoma |
Drug: estramustine phosphate sodium Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkin's Lymphoma |
Study Start Date: | 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.
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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*
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
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 |
Study Chair: | Mitchell R. Smith, MD, PhD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000068773, FCCC-96026, NCI-G01-1986 |
Study First Received: | July 11, 2001 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00021372 History of Changes |
Health Authority: | United States: Federal Government |
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, Mantle-Cell Estramustine Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Follicular Lymphoma Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Leukemia, B-cell, Chronic Lymphoma, Large-cell Alkylating Agents |
Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Antimitotic Agents Recurrence Lymphatic Diseases Burkitt's Lymphoma Chronic Lymphocytic Leukemia B-cell Lymphomas Paclitaxel Burkitt Lymphoma Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoproliferative Disorders |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Mitosis Modulators Estramustine Antimitotic Agents Pharmacologic Actions Lymphatic Diseases |
Neoplasms Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Alkylating Agents Lymphoma |