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AzTrials

LymphomaPhase 2NCT00079261

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

A Phase 2 study testing CHOP regimen, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma, Small Intestine Cancer
What is being tested?
CHOP regimen, cyclophosphamide and doxorubicin hydrochloride
How many people
25 participants
Where
6 sitesin 5 countries
Study dates
Jan 2004to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

6 sites in 5 countries.

6 sites in 5 countries

Belgium2 sites

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Croatia1 site

  • University Hospital Rebro

    Zagreb, 41000

Other trials in Croatia

Egypt1 site

  • National Cancer Institute - Cairo

    Cairo

Other trials in Egypt

France1 site

  • Institut Bergonie

    Bordeaux, 33076

Other trials in France

Netherlands1 site

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

Other trials in Netherlands

About this study

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

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.

Read the 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.

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
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response as assessed by Cheson criteria

Secondary outcomes (3)

  1. Toxicity as assessed by CTC 2.0

  2. Proportion of courses given as scheduled

  3. Freedom from treatment failure as assessed by Cheson criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079261
Sponsor's protocol ID
EORTC-20021
Other IDs
EORTC-20021
Status last verified
Sep 2012
First submitted
8 Mar 2004
Last updated
24 Sep 2012
Results posted
No

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.

    PubMed 20942843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHOP regimen, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium, Croatia, Egypt, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response as assessed by Cheson criteria. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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