Trial results for the study NCT02122185, investigating metformin hydrochloride in combination with chemotherapy for patients with Stage III-IV ovarian, fallopian tube, or primary peritoneal cancer, were posted on ClinicalTrials.gov on 2026-03-27. The study showed that adding metformin hydrochloride to chemotherapy did not significantly improve progression-free survival or overall survival compared to chemotherapy alone. Median progression-free survival was 15.4 months for the metformin group versus 14.3 months for the placebo group, while median overall survival was 40.7 months versus 43.8 months, respectively.
Background
The trial aimed to evaluate how well metformin hydrochloride and combination chemotherapy work together in treating patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The hypothesis was that metformin hydrochloride might enhance the effectiveness of chemotherapy drugs like carboplatin, paclitaxel, and docetaxel by increasing tumor cell sensitivity to these agents.
Trial design
The study NCT02122185 was a Phase 2 randomized trial that enrolled 111 participants. The trial investigated metformin hydrochloride and chemotherapy in patients diagnosed with Stage III-IV ovarian, fallopian tube, or primary peritoneal cancer, specifically including conditions such as Brenner Tumor, Malignant Ascites, Malignant Pleural Effusion, Ovarian Clear Cell Cystadenocarcinoma, and Ovarian Endometrioid Adenocarcinoma. Participants were randomized to receive either metformin hydrochloride plus chemotherapy or placebo plus chemotherapy.
Key results
The trial evaluated several key outcomes comparing the metformin plus chemotherapy group to the placebo plus chemotherapy group.
For Progression Free Survival (PFS):
- The median PFS for the metformin plus chemotherapy group was 15.4 months.
- The median PFS for the placebo plus chemotherapy group was 14.3 months.
A Log Rank analysis yielded a p-value of 0.31, with a Cox Proportional Hazard of 0.87 (95% Confidence Interval: 0.56 to 1.36), indicating no statistically significant difference.
For Time to Biochemical (CA-125) Progression, Radiological Progression, or Death:
- The median time for the metformin plus chemotherapy group was 14.4 months.
- The median time for the placebo plus chemotherapy group was 13.7 months.
A Log Rank analysis showed a p-value of 0.89, with a Cox Proportional Hazard of 1.03 (95% Confidence Interval: 0.66 to 1.61), indicating no statistically significant difference.
For Overall Survival (OS):
- The median OS for the metformin plus chemotherapy group was 40.7 months.
- The median OS for the placebo plus chemotherapy group was 43.8 months.
A Log Rank analysis resulted in a p-value of 0.21, with a Hazard Ratio (HR) of 1.49 (96% Confidence Interval: 0.86 to 2.29), indicating no statistically significant difference.
Regarding adverse events:
- 19 participants in the metformin plus chemotherapy group experienced adverse events.
- 13 participants in the placebo plus chemotherapy group experienced adverse events.
A Fisher Exact test yielded a p-value of 0.29.
What this means
The results from this Phase 2 trial suggest that adding metformin hydrochloride to standard chemotherapy regimens does not significantly improve progression-free survival, time to progression, or overall survival in patients with Stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. The observed numerical differences in median survival outcomes were not statistically significant, and overall survival was numerically lower in the metformin group. These findings do not support the use of metformin hydrochloride as an adjunct to chemotherapy for these indications based on the current data.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02122185, titled "Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer," were posted on 2026-03-27 on clinicaltrials.gov.