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A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: May 31, 2002
Last updated: January 20, 2012
Last verified: January 2012

For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Filgrastim SD/01
Drug: Paclitaxel
Drug: Topotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 25
Study Start Date: May 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma & transformed lymphoma.)
  • No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks.
  • Not be eligible for treatment of a higher priority.
  • Performance status <2 Zubrod, > 60 Karnofsky.
  • Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.
  • Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values.
  • Serum creatinine < 1.8 mg/dL.
  • Age > 18 yrs.
  • Signed informed consent.
  • Life expectancy of > 12 weeks.
  • No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.
  • No prior stem cell or bone marrow transplantation.
  • No prior second malignancies except for basal cell carcinoma of the skin.


  • Active or prior history of CNS lymphoma.
  • Serious intercurrent medical illnesses requiring hospitalization.
  • History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids).
  • Prior exposure to Filgrastim-SD/01.
  • Women who are pregnant or lactating.
  • Participation in another clinical trial.
  • Positive HIV antibody.
  • History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00038545

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038545     History of Changes
Other Study ID Numbers: DM01-008
Study First Received: May 31, 2002
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Adjuvants, Immunologic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on November 25, 2014