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Colorectal CancerPhase 2NCT00814619

Capecitabine and Radiation Therapy With or Without Panitumumab in Treating Patients With Advanced Rectal Cancer

A Phase 2 study testing panitumumab, capecitabine and therapeutic conventional surgery in people with Colorectal Cancer, run by Swiss Cancer Institute at 24 sites in 2 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 capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
panitumumab, capecitabine and therapeutic conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
24 sitesin 2 countries
Study dates
Nov 2008to Jan 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement
  • Stage mrT3-4 and/or mrN1-2, M0
  • Tumors must express wild type K-ras gene
  • No distant metastasis

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Able to undergo surgery
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 100 g/L
  • Creatinine clearance ≥ 50 mL/min
  • AST ≤ 2.5 times upper limit normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception during and for 12 months after completion of study
  • No malignancy within the past 5 years with the exception of adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer
  • No psychiatric disorder that would preclude understanding study-related information, giving informed consent, or complying with oral drug intake
  • No prior existing conditions that would preclude radiotherapy
  • No clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the past 12 months
  • No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • No serious underlying medical condition that, in the judgement of the investigator, could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes)
  • No known dihydropyrimidine dehydrogenase deficiency
  • No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior treatment in a clinical trial
  • No other concurrent experimental drugs, anticancer therapy, or investigational treatments
  • No prior treatment for rectal cancer
  • No prior anti-EGFR antibody therapy (e.g., cetuximab) or small-molecule EGFR inhibitors (e.g., erlotinib hydrochloride)
  • No concurrent treatment with brivudine, lamivudine, ribavirin, or any other nucleoside analogues
  • No organ allografts
  • No concurrent drugs contraindicated for use with the trial drugs
  • No other concurrent anti-EGFR-targeting agents
  • No other concurrent radiotherapy

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

Switzerland23 sites

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Kantonspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

  • Inselspital Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Kantonsspital Bruderholz

    Bruderholz, CH-4101

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • OnkoZentrum Luzern at Klinik St. Anna

    Lucerne, 6006

  • Kantonsspital, Luzerne

    Luzerne, CH-6000

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hopital Regional de Sion-Herens-Conthey

    Sion, CH -1951

  • Regionalspital

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Onkozentrum

    Zurich, 8038

  • Klinik Hirslanden

    Zurich, CH-8032

  • City Hospital Triemli

    Zurich, CH-8063

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Hungary1 site

  • Szent Laszlo Korhaz

    Budapest, 1097

Other trials in Hungary

About this study

Official title: Neoadjuvant Radiotherapy and Capecitabine With or Without Panitumumab in Patients With Advanced, K-ras Unmutated Rectal Cancer. A Randomized Multicenter Phase II Trial

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as panitumumab, 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. It is not yet known whether giving capecitabine together with 3-D conformal radiation therapy is more effective with or without panitumumab in treating patients with advanced rectal cancer.

PURPOSE: This randomized phase II trial is studying giving capecitabine together with radiation therapy to see how well it works with or without panitumumab in treating patients with advanced rectal cancer.

Read the detailed description

OBJECTIVES:

  • To assess the efficacy and safety of neoadjuvant capecitabine and concurrent 3-dimensional conformal radiotherapy with vs without panitumumab in patients with advanced K-ras unmutated rectal cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, T stage (T3 vs T4), tumor localization measured from caudal part of the tumor to the anocutaneous line (< 10 cm vs ≥ 10 cm), and number of EGFR gene copies (< 2.9 vs ≥ 2.9). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive panitumumab IV over 30-90 minutes on days 1, 15, 29, 43, and 57 and oral capecitabine twice daily on days 8-40. Beginning on day 8, patients undergo daily fractions of 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning approximately 6 weeks after completion of panitumumab and chemoradiotherapy, patients undergo surgery.
  • Arm II: Patients receive oral capecitabine twice daily on days 1-33. Patients undergo concurrent 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning 6 weeks after completion of chemoradiotherapy, patients undergo surgery.

After completion of study therapy, patients are followed periodically for up to 3 years.

Being tested
panitumumab, capecitabine, therapeutic conventional surgery, 3-dimensional conformal radiation therapy
Keywords
adenocarcinoma of the rectum, stage III rectal cancer, stage II rectal cancer
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.

  • panitumumabBiological

    Also called Vectibix

    Given IV

  • capecitabineDrug

    Also called Xeloda

    Given orally

  • therapeutic conventional surgeryProcedure or surgery

    Patients undergo surgical resection

  • 3-dimensional conformal radiation therapyRadiation

    Patients undergo radiotherapy

Study groups in NCT00814619
Study groupRoleWhat they receive
Arm IExperimentalPatients receive panitumumab IV over 30-90 minutes on days 1, 15, 29, 43, and 57 and oral capecitabine twice daily on days 8-40. Beginning on day 8, patients undergo daily fractions of 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning approximately 6 weeks after completion of panitumumab and chemoradiotherapy, patients undergo surgery.
Receives: Biological: panitumumab; Drug: capecitabine; Procedure: therapeutic conventional surgery; Radiation: 3-dimensional conformal radiation therapy
Arm IIActive comparatorPatients receive oral capecitabine twice daily on days 1-33. Patients undergo concurrent 3-D conformal radiotherapy 5 days a week for 5 weeks. Beginning 6 weeks after completion of chemoradiotherapy, patients undergo surgery.
Receives: Drug: capecitabine; Procedure: therapeutic conventional surgery; Radiation: 3-dimensional conformal radiation therapy

What is being measured

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

  1. Pathological complete or near-complete response (Dworak grade 3 and 4)

    Measured: after 13 weeks.

Secondary outcomes (7)

  1. Pathological response

    Measured: after 13 weeks.

  2. R0 or R1 resection

    Measured: after 13 weeks.

  3. Postoperative complications (within 8 weeks after surgery)

    Measured: within 8 weeks after surgery

  4. Time to local relapse

    Measured: calculated from randomization to documented relapse or censored at the last CT and/or endorectal ultrasound without local relapse.

  5. Time to distant failure

    Measured: calculated from randomization to documented distant (metastatic) failure or censored at the last CT without distant (metastatic) failure.

  6. Disease-free survival

    Measured: calculated from randomization to first relapse or death (whichever occurs first).

  7. Adverse events

    Measured: All AEs will be assessed according to NCI CTCAE v3.0.

Timeline

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

  1. First posted25 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMay 2010
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00814619
Sponsor's protocol ID
SAKK 41/07
Other IDs
SWS-SAKK-41-07, EudraCT-2008-006012-38, EU-20894, CDR0000629101
Status last verified
Apr 2014
First submitted
24 Dec 2008
Last updated
30 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Helbling D, Bodoky G, Gautschi O, Sun H, Bosman F, Gloor B, Burkhard R, Winterhalder R, Madlung A, Rauch D, Saletti P, Widmer L, Borner M, Baertschi D, Yan P, Benhattar J, Leibundgut EO, Bougel S, Koeberle D. Neoadjuvant chemoradiotherapy with or without panitumumab in patients with wild-type KRAS, locally advanced rectal cancer (LARC): a randomized, multicenter, phase II trial SAKK 41/07. Ann Oncol. 2013 Mar;24(3):718-25. doi: 10.1093/annonc/mds519. Epub 2012 Nov 8.

    PubMed 23139259

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panitumumab, capecitabine and therapeutic conventional surgery in people with Colorectal Cancer, run by Swiss Cancer Institute at 24 sites in 2 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 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Switzerland, Hungary. 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?

Pathological complete or near-complete response (Dworak grade 3 and 4) (time frame: after 13 weeks.). 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 NCT00814619, 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 30 Apr 2014.

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