AzTrials
AzTrials

Colorectal CancerPhase 3NCT00335595

Study of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy in Metastatic Colorectal Cancer Patients

A Phase 3 study testing XELOXA and XELOXA-A in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the… 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?
XELOXA and XELOXA-A
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteSpain
Study dates
Jul 2006to Jun 2012
Phase
Phase 3
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

Who may be able to join

  • Written informed consent given.
  • Patients who are able to understand the study request.
  • Men and women > or = 18 years, not hospitalized.
  • Outpatients with ECOG performance status ≤ 2.
  • Histologically confirmed diagnosis of colorectal cancer (CRC) patients with metastasis.
  • Presence of at least one detectable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Life expectancy of greater than 3 months.
  • Men and women potentially fertile using an effective contraceptive method

Who cannot join

  • Patients who have been treated with bevacizumab previously.
  • Received any systemic treatment previously to treat an advanced or metastatic disease
  • Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that it has been finished at least 6 months before the initial study treatment.
  • If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during treatment or for 6 months after the end of treatment.
  • If radiotherapy has not been administered in the lesion selected for the study, previous radiotherapy is allowed, unless progression of those injuries can be documented in the radiated field, as long as the end of the treatment has been finished at least 4 weeks before study initiation.
  • Previous surgical procedure of stage IV disease is allowed.
Show all 34Show fewer
  • Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or this study indication, unless there has been a disease-free interval of at least 2 years.
  • History or evidence upon physical examination of central nervous system
  • History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
  • Clinically significant cardiovascular disease (active).
  • Patients who have undergone myocardial infarction or cerebrovascular accident 6 months prior to randomisation will be excluded.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medications.
  • Patients subjected to allogeneic transplant and request immunotherapy.
  • Bone fracture not healed, wounds or severe ulcers.
  • Known hemorrhagic diathesis or coagulopathy.
  • Uncontrolled and severe intercurrent infections or other severe and uncontrolled concomitant diseases.
  • Moderate or severe renal impairment (creatinine clearance < 30 ml/min [calculated according to Cockroft-Gault formula] or serum creatinine ≥ 2 mg/dl or 177 μmol/l).
  • Any of the following laboratory values:
  • Absolute neutrophil count (ANC) ≤ 1.5 x 10^9/l.
  • Platelet count ≤ 100 x 10^9/l.
  • Hemoglobin ≤ 9 g/dl.
  • International Normalized Ratio (INR) ≥ 1.5.
  • Total bilirubin ≥ 1.5 x upper limit of normal (ULN).
  • ALT and/or AST ≥ 2.5 x ULN or ≥ 5 x ULN (in case of hepatic metastasis).
  • Alkaline phosphatase > 2.5 x ULN or 5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis).
  • History of unexpected serious adverse events to fluoropyrimidine treatments or known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patients subjected to major surgical procedure or open biopsy; or patients have had significant traumatic injuries 28 days before the initial study treatment; or patients with a major surgical procedure planned during the study period.
  • Fine needle aspiration biopsy 7 days before study initiation.
  • Use of full dose of oral or parenteral anticoagulants (at least 10 days before the initial study treatment) or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5.
  • Subjects requiring chronic use of high dose aspirin (> 325 mg/day) or non-steroidal anti-inflammatory treatment (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases).
  • Pregnant or lactating women.
  • Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies; or to any excipients of bevacizumab formulation; or to any other study drugs.
  • Received any investigational drug or agent/procedure, i.e. participation in another treatment trial within 30 days of randomisation.
  • Evidence of another disease, metabolic malfunction, discovery in a physical examination or in a clinical laboratory test to result in reasonable suspicion of a condition or disease that contraindicates investigational medicine use or exposes the patient to high risk treatment complications.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, Madrid, 28046

Other trials in Spain

About this study

Official title: Randomized, Multicenter, Phase III Study, to Evaluate the Efficacy and Safety of Bevacizumab Alone or Combined With Capecitabine and Oxaliplatin as Support Therapy After Initial Chemotherapy Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.

Read the detailed description

The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.

Being tested
XELOXA, XELOXA-A
Keywords
colorectal cancer, Bevacizumab, capecitabine, oxaliplatin
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • XELOXADrug

    XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks

  • XELOXA-ADrug

    XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study.

    One cycle every 3 weeks

Study groups in NCT00335595
Study groupRoleWhat they receive
1Active comparatorXELOXA
Receives: Drug: XELOXA
2ExperimentalXELOXA-A
Receives: Drug: XELOXA-A

What is being measured

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

  1. Determine the free time to disease progression

    Measured: 2006-2012

Secondary outcomes (9)

  1. Overall survival

    Measured: 2006-2012

  2. Overall response rate

    Measured: 2006-2012

  3. Time to onset of response

    Measured: 2006-2012

  4. Duration of response

    Measured: 2006-2012

  5. Treatment cycles number

    Measured: 2006-2012

  6. Number of patients who need medicine dose reduction

    Measured: 2006-2012

  7. adverse events

    Measured: 2006-2012

  8. Prognostic and predictive factor of Circulating endothelial cells (CEC) and circulating tumors cells (CTC) baseline and after 3 cycle

    Measured: 2006-2012

  9. Prognostic factor of the K-Ras gene mutation

    Measured: 2006-2012

Timeline

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

  1. First posted12 Jun 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionJun 2012
  4. Study completionJun 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335595
Sponsor's protocol ID
TTD-05-02
Other IDs
EudraCT Nº: 2005-003325-67
Status last verified
Feb 2013
First submitted
9 Jun 2006
Last updated
20 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Sastre J, Maestro ML, Gomez-Espana A, Rivera F, Valladares M, Massuti B, Benavides M, Gallen M, Marcuello E, Abad A, Arrivi A, Fernandez-Martos C, Gonzalez E, Tabernero JM, Vidaurreta M, Aranda E, Diaz-Rubio E. Circulating tumor cell count is a prognostic factor in metastatic colorectal cancer patients receiving first-line chemotherapy plus bevacizumab: a Spanish Cooperative Group for the Treatment of Digestive Tumors study. Oncologist. 2012;17(7):947-55. doi: 10.1634/theoncologist.2012-0048. Epub 2012 May 29.

    PubMed 22643538

  • Diaz-Rubio E, Gomez-Espana A, Massuti B, Sastre J, Reboredo M, Manzano JL, Rivera F, Safont MJ, Montagut C, Gonzalez E, Benavides M, Marcuello E, Cervantes A, Martinez de Prado P, Fernandez-Martos C, Arrivi A, Bando I, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Role of Kras status in patients with metastatic colorectal cancer receiving first-line chemotherapy plus bevacizumab: a TTD group cooperative study. PLoS One. 2012;7(10):e47345. doi: 10.1371/journal.pone.0047345. Epub 2012 Oct 12.

    PubMed 23174912

  • Diaz-Rubio E, Pietrantonio F, de Braud F. Continuing single-agent bevacizumab as maintenance therapy after induction XELOX (or FOLFOX) plus bevacizumab in first-line treatment of metastatic colorectal cancer. Oncologist. 2012;17(11):1426-8. doi: 10.1634/theoncologist.2012-0075. Epub 2012 Oct 16.

    PubMed 23073991

  • Diaz-Rubio E, Gomez-Espana A, Massuti B, Sastre J, Abad A, Valladares M, Rivera F, Safont MJ, Martinez de Prado P, Gallen M, Gonzalez E, Marcuello E, Benavides M, Fernandez-Martos C, Losa F, Escudero P, Arrivi A, Cervantes A, Duenas R, Lopez-Ladron A, Lacasta A, Llanos M, Tabernero JM, Anton A, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors. First-line XELOX plus bevacizumab followed by XELOX plus bevacizumab or single-agent bevacizumab as maintenance therapy in patients with metastatic colorectal cancer: the phase III MACRO TTD study. Oncologist. 2012;17(1):15-25. doi: 10.1634/theoncologist.2011-0249. Epub 2012 Jan 10.

    PubMed 22234633

  • Sastre J, Vidaurreta M, Gomez A, Rivera F, Massuti B, Lopez MR, Abad A, Gallen M, Benavides M, Aranda E, Rubio ED; Spanish Cooperative Group for the Treatment of Digestive Tumors. Prognostic value of the combination of circulating tumor cells plus KRAS in patients with metastatic colorectal cancer treated with chemotherapy plus bevacizumab. Clin Colorectal Cancer. 2013 Dec;12(4):280-6. doi: 10.1016/j.clcc.2013.06.001. Epub 2013 Sep 5.

    PubMed 24012456

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XELOXA and XELOXA-A in people with Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 8 inclusion and 34 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 20 Feb 2013. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Determine the free time to disease progression (time frame: 2006-2012). 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 NCT00335595, which also lists 5 linked publications.

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 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

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