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Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00079261
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE March 8, 2004
First Posted Date  ICMJE March 10, 2004
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE January 2004
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Complete response as assessed by Cheson criteria
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Toxicity as assessed by CTC 2.0
  • Proportion of courses given as scheduled
  • Freedom from treatment failure as assessed by Cheson criteria
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Official Title  ICMJE Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

  • Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone with vs without gemcitabine.

Secondary

  • Compare the safety profile of these regimens in these patients.
  • Compare the feasibility of these regimens, defined as the proportion of courses given as scheduled, in these patients.
  • Compare freedom from treatment failure in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to participating center, International Prognostic Index score (0-2 vs 3-5), and histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.
  • Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.

In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease. Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8 courses).

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Small Intestine Cancer
Intervention  ICMJE
  • Drug: CHOP regimen
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: gemcitabine hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
Study Arms  ICMJE Not Provided
Publications * Aurer I, Eghbali H, Raemaekers J, Khaled HM, Fortpied C, Baila L, van der Maazen RW; EORTC Lymphoma Group. Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54). Eur J Haematol. 2011 Feb;86(2):111-6. doi: 10.1111/j.1600-0609.2010.01540.x. Epub 2010 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2012)
25
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:

    • Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
    • Grade 3 follicular lymphoma
    • Extranodal T/NK cell lymphoma, nasal type
    • Enteropathy-type T cell lymphoma
    • Hepato-splenic T cell lymphoma
    • Peripheral T cell lymphoma, unspecified
    • Angioimmunoblastic lymphoma
    • Anaplastic large cell lymphoma, systemic type
  • Stage II-IV disease
  • At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
  • The following subtypes are not allowed:

    • Mantle cell lymphoma
    • Burkitt's lymphoma
    • Precursor B or T cell lymphoma
    • Primary cutaneous B or T cell lymphoma
  • No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 to 70

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • WBC > 3,000/mm^3
  • Neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 2.5 times normal (unless due to lymphoma)
  • ALT and AST < 2.5 times normal (unless due to lymphoma)

Renal

  • Creatinine < 2.0 mg/dL

Cardiovascular

  • No severe cardiac disease that would preclude study participation or limit life expectancy

Pulmonary

  • FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
  • No severe pulmonary disease that would preclude study participation or limit life expectancy

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent monoclonal antibodies

Chemotherapy

  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No prior cytotoxic agents
  • No prior treatment for NHL
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Croatia,   Egypt,   France,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079261
Other Study ID Numbers  ICMJE EORTC-20021
EORTC-20021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Igor Aurer, MD, PhD University Hospital Rebro
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP