Phase 3 Colorectal Cancer Trial, Completed NCT00457691 Sponsor: Pfizer Condition: Colorectal Cancer
Back to Colorectal Cancer

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 768 people with colorectal cancer — 386 received a chemotherapy combination called FOLFIRI together with a drug called sunitinib, and 382 received FOLFIRI together with a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how long participants went without their cancer growing or spreading — called "progression-free survival" — and also tracked how long participants lived overall, how many showed a measurable reduction in their tumour, how long those responses lasted, and how participants rated their symptoms over time. The reported data shows that, for the main measure, the FOLFIRI plus sunitinib group went a median (middle value) of 33.6 weeks before their cancer progressed or they died, compared with 36.6 weeks in the FOLFIRI plus placebo group. For overall survival, the reported figures were 87.9 weeks in the sunitinib group and 85.9 weeks in the placebo group. When looking at tumour response, 124 participants in the sunitinib group and 128 in the placebo group showed a confirmed reduction in tumour size. The reported duration of that response was 30.1 weeks in the sunitinib group and 39.0 weeks in the placebo group. For the symptom and quality-of-life scores, the reported data shows multiple measurement points across time; the detailed figures varied between groups and time points, and no single summary figure was provided for the full study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Colorectal Cancer Trial, Completed

NCT00457691
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with colorectal cancer (cancer of the colon or rectum) that has spread to other parts of the body, confirmed by a laboratory test of a tissue or cell sample
  • You have not yet received any treatment for your cancer that has spread, but your doctor has recommended a chemotherapy treatment called FOLFIRI for you
  • Your blood tests show that your organs (such as your liver and kidneys) are working well enough to take part

Who may not be able to join:

  • You have been diagnosed with another type of cancer in the last 3 years
  • You have had full-body radiation therapy in the last 4 weeks, targeted radiation therapy in the last 2 weeks, or radiation treatment that covered more than 30% of your bone marrow
  • You have, or have had, cancer that has spread to the brain, the spine, or the membranes surrounding the brain and spinal cord

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 June 2007
Est. completion
1 March 2010

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia Cyprus 🇨🇿 Czechia 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇪 Ireland 🇲🇽 Mexico 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇹🇭 Thailand 🇺🇦 Ukraine 🇬🇧 United Kingdom

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov