AzTrials
AzTrials

Colorectal CancerNCT00462501

Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer

A study testing bevacizumab, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center 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

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab, fluorouracil and leucovorin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Mar 2007to Feb 2014
Phase
Interventional
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

DISEASE CHARACTERISTICS:

  • Histologically or pathologically confirmed adenocarcinoma of the rectum
  • Clinical stage T1, N1; T2, N1; T3, N0; or T3, N1 by endorectal ultrasonography (ERUS)
  • No bulky N2 disease by either ERUS or MRI
  • No primary fixed or unresectable (clinical stage T4) rectal cancer or recurrent colorectal cancer limited to the pelvis
  • Primary unresectable rectal cancer is defined as a primary rectal tumor which on the basis of either physical exam, ERUS or pelvic MRI is deemed to be adherent or fixed to adjacent pelvic structures
  • Must be a candidate for all of the following:
  • Neoadjuvant chemoradiotherapy
  • Systemic therapy with fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX), and bevacizumab
  • Complete surgical resection via low anterior resection prior to administration of any therapy
  • No low-lying tumors deemed to require an abdominal perineal resection
  • No large or bulky tumors that require a diverting colostomy or placement of an endorectal stent prior to treatment initiation
  • No clinical evidence of metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count > 150,000/mm^3
  • Hemoglobin > 8.0 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No arterial thrombotic event within the past 6 months, including stable or unstable angina, myocardial infarction (MI), or cerebral vascular accident (CVA)
  • Deep venous thrombosis, pulmonary embolus, MI, CVA, atrial fibrillation, or any other conditions occurring more than 6 months ago allowed provided patient is on stable doses of anticoagulant therapy
  • No other medical or psychiatric condition or disease that would preclude study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or surgery for rectal cancer
  • No prior pelvic radiotherapy
  • No other concurrent experimental therapy, including any of the following:
  • Chemotherapy
  • Radiotherapy
  • Hormonal therapy
  • Antibody therapy
  • Immunotherapy
  • Gene therapy
  • Vaccine therapy
  • Angiogenesis inhibitors
  • Matrix metalloprotease inhibitors
  • Thalidomide
  • Anti-vascular endothelial growth factor/Flk-1 monoclonal antibody
  • Any other experimental drugs

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of rectal cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and bevacizumab together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without radiation therapy works in treating patients with locally advanced rectal cancer

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether neoadjuvant chemotherapy comprising oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX), and bevacizumab can be substituted for pelvic radiotherapy without compromising R0 resection rates in patients with locally advanced rectal cancer.

Secondary

  • Determine whether a 3-year local recurrence rate of ≤ 10% can be achieved in patients treated with this regimen.
  • Determine the proportion of patients who achieve a complete pathologic response after treatment with this regimen.

OUTLINE: This is a non-randomized, open-label, pilot study.

  • Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 10 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 1, 3, 5, and 7. Patients then receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11. Treatment continues in the absence of disease progression or unacceptable toxicity.

Within 3 weeks after completion of neoadjuvant chemotherapy, patients undergo restaging evaluation. Patients with no evidence of disease progression by endorectal ultrasound (ERUS), pelvic MRI, and CT scan of the chest/abdomen AND who remain candidates for R0 resection may proceed directly to surgical resection within 4-6 weeks after completion of neoadjuvant chemotherapy. Patients with progressive disease who are not candidates for an R0 resection, proceed to neoadjuvant chemoradiotherapy.

  • Neoadjuvant chemoradiotherapy: Patients undergo pelvic radiotherapy 5 days a week and receive concurrent fluorouracil IV continuously for 5½ weeks. Within 4-7 weeks after completion of chemoradiotherapy, patients undergo surgical resection.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Keywords
stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

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

Study groups in NCT00462501
Study groupRoleWhat they receive
Chemotherapy and Bevacizumab With or Without RadiationExperimentalFOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
Receives: Biological: bevacizumab; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

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

  1. Complete Pathologic Response

    This will be assessed on the basis of the surgical pathology report.

    Measured: 3 years

Timeline

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

  1. First posted19 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462501
Sponsor's protocol ID
07-021
Other IDs
P30CA008748, MSKCC-07021
Status last verified
Dec 2015
First submitted
18 Apr 2007
Last updated
20 Jan 2016

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center 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?

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 20 Jan 2016. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). 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?

Complete Pathologic Response (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jan 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in