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AzTrials

Contiguous Stage II Adult Diffuse Large Cell LymphomaPhase 2NCT00121199

Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma

A Phase 2 study testing rituximab, bevacizumab and cyclophosphamide in people with Contiguous Stage II Adult Diffuse Large Cell Lymphoma and Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rituximab, bevacizumab and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
Jun 2005to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have previously untreated Stage III, IV, or bulky Stage II diffuse large B-cell non-Hodgkin's lymphoma which is positive for CD20; a report providing confirmation of CD20 expression must be submitted
  • Pathology Review: Adequate sections from the original diagnostic specimen must be available for submission for review by the SWOG Lymphoma Pathology Laboratory; an adequate biopsy requires sufficient tissue to establish the architecture and a REAL or WHO histologic subtype with certainty; thus, core biopsies, especially multiple core biopsies may be adequate; whereas, needle aspirations or cytologies are not adequate
  • Specimens for analysis of angiogenic markers must be submitted to the University of Arizona
  • All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 42 days prior to registration
  • Patients must have a unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
  • Patients must have a CT scan of the chest/abdomen and pelvis performed within 28 days prior to registration
Show all 32Show fewer
  • Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration
  • Patients may not have a previous diagnosis of indolent lymphoma (histologic transformation or mixed histologies with an indolent or nodular component are ineligible)
  • Patients must not have received prior chemotherapy, radiation, or antibody-based therapy for lymphoma
  • Patients must have a Zubrod performance status of 0 - 2
  • Serum LDH must be measured within 28 days prior to registration
  • Patients must have a cardiac ejection fraction >= 45% by MUGA scan or a 2-d ECHO with no significant abnormalities within 42 days prior to registration
  • Absolute neutrophil count > 1,000/mcL obtained within 28 days prior to registration
  • Platelet count > 100,000/mcL obtained within 28 days prior to registration
  • Serum creatinine < 2 x the institutional upper limit of normal within 28 days prior to registration
  • Patients must have urine proteinuria screened by dipstick or urine analysis within 28 days prior to registration; in patients with proteinuria >= +1 or urine protein:creatinine ratio >= 1.0, a 24 hour urine protein should be obtained and the level < 1gm/24 hours to be eligible
  • Patients must not have a history of hypersensitivity reaction to products containing Polysorbate 20 (Tween 20), Chinese hamster ovary cell products, or recombinant human antibodies
  • Patients known to be HIV-positive, or who have a history of solid organ transplantation are ineligible due to the concern over immunosuppression associated with B-cell depletion; patients at high risk of Hepatitis B virus infection should be screened before initiation of rituximab
  • Patients must not have uncontrolled hypertension
  • Patients with a history of prior myocardial infarction, unstable angina, stroke, or arterial thrombosis within 6 months are ineligible
  • Patients with clinically significant peripheral vascular disease, a serious or non-healing wound, ulcer, or bone fracture, or a bleeding diathesis/coagulopathy are ineligible
  • Patients with a history of venous thrombosis requiring full-dose anticoagulation or currently receiving anticoagulation therapy may be eligible provided that the following criteria are met:
  • The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on a stable dose of LMW heparin
  • The patient must not have bleeding or pathological conditions that carry a high risk of bleeding (e.g. tumor involving major vessels, known varices)
  • Patients who have had a major surgical procedure or traumatic injury within 28 days prior to registration or anticipation of major surgical procedure during the course of therapy are ineligible
  • Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months are ineligible
  • Patients requiring continuous supplemental oxygen therapy are ineligible
  • No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for five years
  • Pregnant or nursing women may not participate in this study due to the potential for congenital abnormalities, and of harm to nursing infants due to this treatment regimen; women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the study period and for at least 6 months after the completion of therapy
  • If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • SWOG

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL

This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the 1-year progression-free survival rate in patients with advanced stage diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab.

II. To estimate the response rate (complete, complete unconfirmed, and partial) and 2-year progression-free survival of this regimen in patients with advanced stage diffuse large B-cell NHL.

III. To evaluate the toxicities associated with this regimen. IV. To correlate angiogenic biomarkers with patient outcome.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 6 months for 2 years and then annually for 3 years.

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • bevacizumabBiological

    Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

    Given IV

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • vincristine sulfateDrug

    Also called leurocristine sulfate, VCR, Vincasar PFS

    Given IV

  • prednisoneDrug

    Also called DeCortin, Deltra

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00121199
Study groupRoleWhat they receive
Treatment (CHOP, rituximab, bevacizumab)ExperimentalPatients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: rituximab; Biological: bevacizumab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate; Drug: prednisone; Other: laboratory biomarker analysis

What is being measured

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

  1. Progression-free Survival at 1 Year

    Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

    Measured: 0-1 year

  2. Progression-free Survival at 2 Year

    Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

    Measured: 0-2 years

Secondary outcomes (2)

  1. Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))

    Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

    Measured: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.

  2. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

    Measured: Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment

Timeline

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

  1. First posted21 Jul 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2010
  4. Study completionDec 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121199
Sponsor's protocol ID
NCI-2012-03062
Other IDs
NCI-2012-03062, S0515, S0515, U10CA032102
Status last verified
Dec 2012
First submitted
19 Jul 2005
Last updated
21 May 2014

Publications

  • Stopeck AT, Unger JM, Rimsza LM, LeBlanc M, Farnsworth B, Iannone M, Glenn MJ, Fisher RI, Miller TP. A phase 2 trial of standard-dose cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and rituximab plus bevacizumab for patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: SWOG 0515. Blood. 2012 Aug 9;120(6):1210-7. doi: 10.1182/blood-2012-04-423079. Epub 2012 Jun 25.

    PubMed 22734071

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, bevacizumab and cyclophosphamide in people with Contiguous Stage II Adult Diffuse Large Cell Lymphoma and Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. 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 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 19 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival at 1 Year (time frame: 0-1 year). The study lists 2 primary outcomes in all. 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 NCT00121199, 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 21 May 2014.

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