AzTrials
AzTrials

Metastatic Colorectal CancerPhase 2NCT00865709

Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) in people with Metastatic Colorectal Cancer, run by Bayer at 116 sites in 10 countries.

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

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
116 sitesin 10 countries
Study dates
Mar 2009to Feb 2012
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

  • Histological confirmation of adenocarcinoma of the colon or rectum
  • Tumor tissue sample available for KRAS and BRAF assessment
  • Measurable metastatic Stage IV disease including at least one measurable lesion that has not previously been radiated
  • No prior chemotherapy for metastatic CRC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and renal function; adequate clotting parameters

Who cannot join

  • Prior treatment with sorafenib
  • Clinical or radiographic evidence of brain metastasis
  • Major surgery, surgical biopsy, or significant traumatic injury within 28 days of randomization; evidence or history of bleeding diathesis or coagulopathy
  • Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
  • Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
  • Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within 28 days before randomization
Show all 19Show fewer
  • Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semi-permanent central venous port for administration of chemotherapy is allowed. The use of coumadin and related compounds is excluded.)
  • Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management
  • Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization
  • Active cardiac disease including:
  • Congestive heart failure
  • Unstable angina or myocardial infarction within the 6 months before randomization
  • Cardiac ventricular arrhythmias requiring antiarrhythmic treatment
  • Peripheral neuropathy > Grade 1 (CTCAE)
  • Known HIV infection or chronic hepatitis B or C infection
  • Any active infection >/= Grade 2 (CTCAE)
  • Any medical, psychological, or social condition that may interfere with the subject's participation in the study or evaluation of the study results
  • Use of any investigational drug within 28 days or 5 half-lives of that drug, whichever is longer, before randomization
  • Subjects with metastatic CRC who are currently candidates for surgery with curative intent

Trial locations and contacts

116 sites in 10 countries.

116 sites in 10 countries

Russia33 sites

  • Study site

    Arkhangelsk, 163045

  • Study site

    Astrakhan, 414041

  • Study site

    Chelyabinsk, 454087

  • Study site

    Irkutsk, 664035

  • Study site

    Ivanovo, 153013

  • Study site

    Izhevsk, 426009

  • Study site

    Kazan', 420029

  • Study site

    Khabarovsk, 680022

  • Study site

    Krasnodar, 350040

  • Study site

    Kursk, 305035

  • Study site

    Magnitogorsk, 455001

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 121356

  • Study site

    Moscow, 129128

  • Study site

    Nizhny Novgorod, 603001

  • Study site

    Novosibirsk, 630047

  • Study site

    Obninsk, 249036

  • Study site

    Pjatygorsk, 357502

  • Study site

    Rostov-on-Don, 350086

  • Study site

    Saint Petersburg, 191104

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197110

  • Study site

    Saint Petersburg, 198255

  • Study site

    Samara, 443031

  • Study site

    Sochi, 354057

  • Study site

    Syktyvkar, 167904

  • Study site

    Tula, 300053

  • Study site

    Ulyanovsk, 432063

  • Study site

    Vladimir, 600020

  • Study site

    Volgograd, 400138

  • Study site

    Yaroslavl, 150054

  • Study site

    Yekaterinburg, 620036

Other trials in Russia

Ukraine13 sites

  • Study site

    Cherkassy, 18009

  • Study site

    Dnipro, 49102

  • Study site

    Dnipropetrovsk, 49055

  • Study site

    Donetsk, 83092

  • Study site

    Ivano-Frankivsk, 76000

  • Study site

    Kharkiv, 61070

  • Study site

    Kiev, 03022

  • Study site

    Kryvyi Rih, 50048

  • Study site

    Luhansk, 91047

  • Study site

    Lviv, 79031

  • Study site

    Mariupol, 87500

  • Study site

    Sumy, 40005

  • Study site

    Uzhhorod, 88014

Other trials in Ukraine

United Kingdom12 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Belfast, BT7 1NN

  • Study site

    Bristol, Avon, BS2 8ED

  • Study site

    Glasgow, G61 1BD

  • Study site

    Hull, HU8 9HE

  • Study site

    Liverpool, Merseyside, L7 8XP

  • Study site

    London, WC1E 6BT

  • Study site

    Manchester, Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Northwood, Middlesex, HA6 2RN

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Spain11 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28041

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Manresa, Barcelona, 08240

  • Study site

    Palma de Mallorca, Illes Baleares, 07010

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 46009

  • Study site

    Valencia, Valencia, 46010

Other trials in Spain

Poland10 sites

  • Study site

    Bialystok, 15-027

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80-952

  • Study site

    Gdynia, 81-519

  • Study site

    Krakow, 31-115

  • Study site

    Krakow, 31-501

  • Study site

    Olsztyn, 10-228

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 53-413

Other trials in Poland

Romania10 sites

  • Study site

    Alba Iulia, 510039

  • Study site

    Baia Mare, 430031

  • Study site

    Bucharest, 022326

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Craiova-Dolj, 200535

  • Study site

    Iași, 700106

  • Study site

    Oradea, 410032

  • Study site

    Suceava, 720237

  • Study site

    Timișoara, 300239

Other trials in Romania

Hungary8 sites

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1106

  • Study site

    Debrecen, 4032

  • Study site

    Győr, 9024

  • Study site

    Kecskemét, 6000

  • Study site

    Szeged, 6720

  • Study site

    Székesfehérvár, 8000

Other trials in Hungary

Italy8 sites

  • Study site

    Castelfranco Veneto, Treviso, 31033

  • Study site

    Genova, 16132

  • Study site

    Palermo, 90146

  • Study site

    Pordenone, 33170

  • Study site

    Province of Macerata, 62100

  • Study site

    Torino, 10153

  • Study site

    Udine, 33100

  • Study site

    Verona, 37134

Other trials in Italy

Belgium6 sites

  • Study site

    Antwerp, 2020

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

United States5 sites

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Dallas, Texas, 75246

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

Being tested
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin), Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Keywords
Colorectal Cancer, Metastasis, Stage IV, Liver Metastasis
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)Drug

    Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)

  • Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)Drug

    Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease

Study groups in NCT00865709
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6ExperimentalSubjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Matching placebo + mFOLFOX6Placebo comparatorSubjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
Receives: Drug: Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)

What is being measured

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

  1. Progression-Free Survival (PFS)

    Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.

    Measured: From randomization of the first subject until 23 months later, assessed every 8 weeks.

Secondary outcomes (4)

  1. Overall Survival (OS)

    Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: From randomization of the first subject until 33 months later.

  2. Time to Progression (TTP)

    Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.

    Measured: From randomization of the first subject until 23 months later, assessed every 8 weeks.

  3. Overall Response

    Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.

    Measured: From randomization of the first subject until 23 months later, assessed every 8 weeks.

  4. Duration of Response

    Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.

    Measured: From randomization of the first subject until 23 months later, assessed every 8 weeks

Timeline

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

  1. First posted19 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJan 2011
  4. Study completionFeb 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00865709
Sponsor's protocol ID
13162
Other IDs
2008-005025-11, 2008
Status last verified
Nov 2014
First submitted
2 Feb 2009
Last updated
11 Dec 2014
Data monitoring committee
Yes

Publications

  • Tabernero J, Garcia-Carbonero R, Cassidy J, Sobrero A, Van Cutsem E, Kohne CH, Tejpar S, Gladkov O, Davidenko I, Salazar R, Vladimirova L, Cheporov S, Burdaeva O, Rivera F, Samuel L, Bulavina I, Potter V, Chang YL, Lokker NA, O'Dwyer PJ. Sorafenib in combination with oxaliplatin, leucovorin, and fluorouracil (modified FOLFOX6) as first-line treatment of metastatic colorectal cancer: the RESPECT trial. Clin Cancer Res. 2013 May 1;19(9):2541-50. doi: 10.1158/1078-0432.CCR-13-0107. Epub 2013 Mar 26.

    PubMed 23532888

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin) in people with Metastatic Colorectal Cancer, run by Bayer at 116 sites in 10 countries.

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 7 inclusion and 19 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Russia, Ukraine, United Kingdom, Spain, Poland and 5 more countries. 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. Some participants in this study may receive a placebo. 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 20 Mar 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 (PFS) (time frame: From randomization of the first subject until 23 months later, assessed every 8 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 NCT00865709, 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 11 Dec 2014.

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