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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00079261
First received: March 8, 2004
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Complete response as assessed by Cheson criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
  • Proportion of courses given as scheduled [ Designated as safety issue: No ]
  • Freedom from treatment failure as assessed by Cheson criteria [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079261

Locations
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
Croatia
University Hospital Rebro
Zagreb, Croatia, 41000
Egypt
National Cancer Institute - Cairo
Cairo, Egypt
France
Institut Bergonie
Bordeaux, France, 33076
Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Igor Aurer, MD, PhD University Hospital Rebro
  More Information

Additional Information:
Publications:
Aurer I, Eghbali H, Raemaekers JM, et al.: 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. [Abstract] Blood 112 (11): A-3609, 2008.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00079261     History of Changes
Other Study ID Numbers: EORTC-20021, EORTC-20021
Study First Received: March 8, 2004
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
adult grade III lymphomatoid granulomatosis
small intestine lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Cyclophosphamide
Gemcitabine
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014