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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CHOP regimen

cyclophosphamide

doxorubicin hydrochloride

gemcitabine hydrochloride

prednisone

vincristine sulfate

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

U.Z. Gasthuisberg
Algemeen Ziekenhuis Sint-Augustinus
University Hospital Rebro
National Cancer Institute - Cairo
Institut Bergonie
Universitair Medisch Centrum St. Radboud - Nijmegen

Outcomes

Primary Outcome Measures

Complete response as assessed by Cheson criteria

Secondary Outcome Measures

Toxicity as assessed by CTC 2.0

Proportion of courses given as scheduled

Freedom from treatment failure as assessed by Cheson criteria

Full Information

NCT ID

NCT00079261

First Posted

March 8, 2004

Last Updated

September 20, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT00079261

Brief Title

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

Official Title

Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Small Intestine Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CHOP regimen

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Primary Outcome Measure Information:

Title

Complete response as assessed by Cheson criteria

Secondary Outcome Measure Information:

Title

Toxicity as assessed by CTC 2.0

Title

Proportion of courses given as scheduled

Title

Freedom from treatment failure as assessed by Cheson criteria

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Igor Aurer, MD, PhD

Organizational Affiliation

University Hospital Rebro

Official's Role

Study Chair

Facility Information:

Facility Name

U.Z. Gasthuisberg

City

Leuven

ZIP/Postal Code

B-3000

Country

Belgium

Facility Name

Algemeen Ziekenhuis Sint-Augustinus

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

University Hospital Rebro

City

Zagreb

ZIP/Postal Code

41000

Country

Croatia

Facility Name

National Cancer Institute - Cairo

City

Cairo

Country

Egypt

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Universitair Medisch Centrum St. Radboud - Nijmegen

City

Nijmegen

ZIP/Postal Code

NL-6500 HB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

20942843

Citation

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.

Results Reference

result

Lymphoma, Small Intestine Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial