# CALGB 90401

Source: https://onco.cc/trials/calgb-90401/  
OnCo record `calgb-90401` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the anti-angiogenic antibody bevacizumab to chemotherapy delayed progression and shrank more tumours, but men did not live longer and four times as many died of the treatment.

## Summary

CALGB 90401 randomly assigned 1,050 men with chemotherapy-naive progressive metastatic castration-resistant prostate cancer to docetaxel and prednisone with bevacizumab 15 mg/kg every 3 weeks or placebo.

Median overall survival was 22.6 months with bevacizumab against 21.5 months without, hazard ratio 0.91 (95 percent confidence interval 0.78 to 1.05, stratified log-rank p=0.181). Median progression-free survival was better with bevacizumab, 9.9 against 7.5 months (stratified log-rank p<0.001), as was objective response, 49.4 against 35.5 percent (p=0.0013).

The harm is in the safety table. Grade 3 or greater treatment-related toxicity occurred in 75.4 percent with bevacizumab against 56.2 percent (p at most 0.001), and treatment-related deaths in 4.0 against 1.2 percent (p=0.005).

An intervention that improves progression-free survival and objective response while quadrupling the treatment-related death rate and not extending life is the clearest possible argument against reading those endpoints as proxies for benefit. Bevacizumab is not used in prostate cancer.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-25
- Also known as: CALGB 90401; Alliance 90401; bevacizumab with docetaxel in mCRPC
- Registry id: NCT00110214
- Phase: 3
- Setting: Chemotherapy-naive progressive metastatic castration-resistant prostate cancer with ECOG performance status 2 or better: docetaxel 75 mg/m2 over 1 hour every 21 days with prednisone 5 mg twice daily, plus bevacizumab 15 mg/kg every 3 weeks or placebo, with overall survival as the primary endpoint
- Sponsor: Cancer and Leukemia Group B, now part of the Alliance for Clinical Trials in Oncology, funded by the National Cancer Institute
- Enrolled: 1050
- Result: Median overall survival 22.6 against 21.5 months (hazard ratio 0.91, 95 percent confidence interval 0.78 to 1.05, p=0.181) despite progression-free survival 9.9 against 7.5 months and response 49.4 against 35.5 percent; treatment-related deaths 4.0 against 1.2 percent.
- Outcomes: Overall survival (median): Docetaxel, prednisone and bevacizumab 22.6 months vs Docetaxel and prednisone 21.5 months, HR 0.91; Progression-free survival (median): Docetaxel, prednisone and bevacizumab 9.9 months vs Docetaxel and prednisone 7.5 months; Treatment-related deaths: Docetaxel, prednisone and bevacizumab 4% vs Docetaxel and prednisone 1.2%
- Replication: COMET-1 with cabozantinib and 10TASQ10 with tasquinimod produced the same dissociation; no anti-angiogenic agent has improved survival in prostate cancer.

## Sources

- ClinicalTrials.gov NCT00110214: https://clinicaltrials.gov/study/NCT00110214
- CALGB 90401 (Journal of Clinical Oncology 2012): https://doi.org/10.1200/JCO.2011.39.4767

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Docetaxel](https://onco.cc/drugs/docetaxel/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Alliance for Clinical Trials in Oncology](https://onco.cc/companies/alliance-oncology/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/), [Prostate cancer programmes that failed, and what each failure taught](https://onco.cc/terms/prostate-failed-programmes/)
- trials: [COMET-1](https://onco.cc/trials/comet-1/), [READY](https://onco.cc/trials/ready-dasatinib/), [TAX 327](https://onco.cc/trials/tax-327/)

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