Table 2. The ongoing and upcoming clinical trials with metformin in cancer therapy (63).
| Study | ClinicalTrials.gov identifier | Conditions | Interventions |
|---|---|---|---|
| Exercise and metformin in colorectal and breast cancer survivors | NCT01340300 | Colorectal cancer; breast cancer | Behavioral: exercise training; drug: exercise training plus metformin; drug: metformin; other: educational information |
| Effect of metformin on breast cancer metabolism | NCT01266486 | Breast cancer | Drug: metformin |
| Temsirolimus in combination with metformin in patients with advanced cancers | NCT01529593 | Advanced cancers | Drug: temsirolimus; drug: metformin |
| Clinical and biologic effects of metformin in early stage breast cancer | NCT00897884 | Breast cancer | Drug: metformin |
| Metformin and endometrial cancer | NCT01205672 | Endometrial cancer | Drug: metformin |
| A trial of standard chemotherapy with metformin (vs. placebo) in women with metastatic breast cancer | NCT01310231 | Metastatic breast cancer | Drug: metformin; drug: placebo |
| Metformin plus modified FOLFOX 6 in metastatic pancreatic cancer | NCT01666730 | Acinar cell adenocarcinoma of the pancreas; duct cell adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer | Drug: metformin hydrochloride; drug: oxaliplatin; drug: leucovorin calcium; drug: fluorouracil; other: laboratory biomarker analysis |
| Phase II study of metformin for reduction of obesity-associated breast cancer risk | NCT02028221 | Breast cancer prevention | Drug: metformin; drug: placebo |
| Metformin hydrochloride as first-line therapy in treating patients with locally advanced or metastatic prostate cancer | NCT01243385 | Prostate cancer | Drug: metformin hydrochloride |
| Pre-surgical trial of the combination of metformin and atorvastatin in newly diagnosed operable breast cancer | NCT01980823 | Breast cancer; breast tumors; cancer of breast | Drug: metformin, atorvastatin combination |
| Impact of pretreatment with metformin on colorectal cancer stem cells (CCSC) and related pharmacodynamic markers | NCT01440127 | Colon cancer | Drug: metformin |
| Metformin hydrochloride vs. placebo in overweight or obese patients at elevated risk for breast cancer | NCT01793948 | Breast cancer; obesity | Drug: metformin hydrochloride; other: placebo; other: laboratory biomarker analysis |
| Evaluation of metformin, targeting cancer stem cells for prevention of relapse in GYN patients | NCT01579812 | Ovarian, fallopian tube, and primary peritoneal cancer | Drug: metformin |
| Effect of metformin on biomarkers of colorectal tumor cell growth | NCT01632020 | Colorectal neoplasms | Drug: placebo; drug: metformin |
| Metformin in children with relapsed or refractory solid tumors | NCT01528046 | Solid tumors; primary brain tumors | Drug: vincristine sulfate; drug: irinotecan; drug: temozolomide; drug: metformin |
| Metformin hydrochloride in treating patients with prostate cancer undergoing surgery | NCT01433913 | Adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIA prostate cancer; stage IIB prostate cancer | Drug: metformin hydrochloride; other: placebo; other: laboratory biomarker analysis |
| Metformin hydrochloride in treating women with stage I or stage II breast cancer that can be removed by surgery | NCT00984490 | Breast cancer | Drug: metformin hydrochloride; other: laboratory biomarker analysis |
| Castration compared to castration plus metformin as first line treatment for patients with advanced prostate cancer | NCT01620593 | Prostate cancer | Drug: placebo and castration; drug: metformin and castration |
| Metformin with the levonorgestrel-releasing intrauterine device for the treatment of complex atypical hyperplasia (CAH) and endometrial cancer (EC) in non-surgical patients | NCT02035787 | Complex atypical hyperplasia; endometrial cancer | Drug: metformin |
| Metformin hydrochloride, carboplatin, and paclitaxel in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer | NCT02050009 | Ovarian papillary serous carcinoma; ovarian serous cystadenocarcinoma; recurrent fallopian tube cancer; recurrent ovarian epithelial cancer; recurrent ovarian germ cell tumor; recurrent primary peritoneal cavity cancer | Drug: metformin hydrochloride; drug: carboplatin; drug: paclitaxel; other: laboratory biomarker analysis |
| The metformin active surveillance trial (MAST) study | NCT01864096 | Prostate cancer | Drug: metformin; drug: placebo |
| Metformin plus irinotecan for refractory colorectal cancer | NCT01930864 | Colorectal neoplasms; adenocarcinoma | Drug: metformin; drug: irinotecan |
| Metformin-docetaxel association in metastatic hormone-refractory prostate cancer | NCT01796028 | Prostatic neoplasms | Drug: metformin; drug: placebo; drug: taxotere® |
| Metformin combined with gemcitabine as adjuvant therapy for pancreatic cancer after curative resection | NCT02005419 | Stage IA pancreatic adenocarcinoma; stage IB pancreatic adenocarcinoma; stage IIA pancreatic adenocarcinoma; stage IIB pancreatic adenocarcinoma | Drug: gemcitabine; drug: metformin; drug: placebo |
| An endometrial cancer chemoprevention study of metformin | NCT01697566 | Gynecology | Drug: metformin; other: placebo; procedure: endometrial biopsy; behavioral: lifestyle intervention; behavioral: questionnaires |
| Metformin and 5-fluorouracil for refractory colorectal cancer. | NCT01941953 | Metastatic colorectal cancer | Drug: metformin and fluorouracil |
| Metformin and temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma | NCT00659568 | Breast cancer; endometrial cancer; kidney cancer; lung cancer; lymphoma; unspecified adult solid tumor, protocol specific | Drug: metformin hydrochloride; drug: temsirolimus |
| Metformin in castration-resistant prostate cancer | NCT01215032 | Prostate cancer | Drug: metformin |
| Metformin and carbohydrate restriction with platinum based chemotherapy in stage IV NS-NSCLC | NCT02019979 | Non-small cell lung cancer stage IIIB; non-small cell lung cancer metastatic; non squamous non-small cell neoplasm of lung | Drug: metformin; behavioral: carbohydrate restricted diet |
| Study of erlotinib and metformin in triple negative breast cancer | NCT01650506 | Breast cancer | Drug: metformin; drug: erlotinib |
| a study with or without metformin to determine if metformin can prevent weight gain and other problems (i.e., diabetes, increased cholesterol, etc.) that can arise from the use of hormonal therapy in combination with radiation therapy when treating aggressive localized prostate cancer | NCT01996696 | Prostatic neoplasm | Drug: metformin; drug: placebo |
| Studying changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32 | NCT01666171 | Breast cancer | Drug: metformin hydrochloride; other: clinical observation; other: diagnostic laboratory biomarker analysis; other: imaging biomarker analysis; other: medical chart review; Procedure: digital mammography |
| Lapatinib with sirolimus or metformin | NCT01087983 | Advanced cancers | Drug: lapatinib; drug: sirolimus; drug: metformin |
| RAD/letrozole/metformin | NCT01797523 | Endometrial cancer | Drug: metformin; drug: letrozole; drug: everolimus |
| Study of biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32 | NCT01286233 | Breast cancer; depression; fatigue; sleep disorders | Drug: metformin; drug: placebo |
| Effect of metformin on decrement in levothyroxin dose required for thyroid stimulating hormone (TSH) suppression in patients with differentiated thyroid cancer | NCT01341886 | Malignant neoplasm of thyroid stage I; malignant neoplasm of thyroid stage II | Drug: metformin |
| Phase I factorial trial of temozolomide, memantine, mefloquine, and metformin for post-radiation therapy (RT) glioblastoma multiforme (GBM) | NCT01430351 | Brain cancer | Drug: temozolomide; drug: memantine; drug: mefloquine; drug: metformin |
| Metformin in stage IV lung adenocarcinoma | NCT01997775 | Non-small cell lung cancer | Drug: metformin |
| A randomized, placebo-controlled, double-blind phase II study evaluating if glucophage can avoid liver injury due to chemotherapy associated steatosis | NCT01523639 | Colorectal cancer; steatohepatitis | Drug: metformin/placebo |
NSCLC, non-small cell lung cancer.