The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 3 May 2021
• Main ID: NCT02394652
• Date of registration: 16/03/2015
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial
• Scientific title: The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial
• Date of first enrolment: May 21, 2015
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02394652
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Kathy Han, M.D.
• Affiliation: Princess Margaret Cancer Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous
carcinoma of the cervix, FIGO stage IB2-IVA

- Planned for radical radiotherapy and concurrent cisplatin chemotherapy.

- Able to receive weekly cisplatin.

- No prior anticancer treatment for cervical cancer

- ECOG 0 or 1

- Life expectancy of greater than 3 months.

- Normal organ and marrow function

- Able to take oral medications.

- Ability to understand and willing to sign the consent form

- Willing to undergo biopsies of cervical tumor.

Exclusion Criteria:

- Evidence of distant metastases

- Receiving any other investigational agents concurrently or within 4 weeks.

- Known diabetes mellitus.

- Currently taking metformin, sulfonylureas, thiazolidinediones or insulin.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to metformin or cisplatin.

- Any condition associated with increased risk of metformin-associated lactic acidosis

- Uncontrolled inter-current illness

- Pregnant women

- History of another invasive malignancy, except for non-melanoma skin cancer or tumors
curatively treated with no evidence of disease for >=5 years.

- Known HIV-positive

- History of bowel obstruction or malabsorption syndromes

- History of active clinically significant bleeding

- Contraindications to radiotherapy

- Taking drug disulfiram (antabuse).



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Squamous Cell Carcinoma

Carcinoma, Adenosquamous

Uterine Cervical Neoplasms

Adenocarcinoma

Intervention(s)

Drug: Metformin

Drug: Cisplatin

Drug: FAZA

Primary Outcome(s)

• Change in fractional hypoxic volume of the tumor on FAZA-PET scan before and after 1 week of metformin. [Time Frame: About 7 days]

Secondary Outcome(s)

Acute and late gastrointestinal and genitourinary toxicities following metformin and chemoradiation. [Time Frame: 2 years]

Disease-free survival [Time Frame: 2 years]

Biomarkers of response to metformin. [Time Frame: 2 years]

Effect of metformin on endogenous hypoxia and other markers. [Time Frame: About 7 days]

Secondary ID(s)

CXMET1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors