Phase II study of anti-cancer activity of metformin patients with advanced solid tumors

Randomized Phase II Study of Palliative Chemotherapy plus Controlled Diet with/ or without Metformin in Patients with Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005210

Enrollment

188

Registered

2020-07-08

Start date

2014-02-26

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1) Experimental arm Non-small cell lung cancer: Metformin (1000mg bid daily, PO)+Gemcitabine 1,000 mg/m2 (D1, D8, IV)+carboplatin AUC 5 (D1, IV), per 3 weeks, until 6 cycles Small cell lung ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. cytologically or histologically confirmed diagnosis of nonsmall cell lung cancer or small cell lung cancer 2. 18 years of age or older 3. a performance status (PS) of = 2 on the Eastern Cooperative Oncology Group (ECOG) scale 4. at least one measurable or evaluable tumour lesion 5. adequate organ function and normal hematologic function

Exclusion criteria

Exclusion criteria: 1. previous systemic chemotherapy (ex: monoclonal antibody) 2. previous radiation therapy without no progression on target lesions within radiation portal. 3. Active interstitial lung disease (radiation change without symptom would be permitted) 4. Invasive malignant tumor history within 5 years except skin basal carcinoma. Cervical in situ carcinoma, and thyroid cancer 5. Brain metastasis or leptomeningeal carcinomatosis requiring steroid with neurologic abnormality 6. History of metformin administration within 3 months 7. Known EGFR mutations

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
overall survival	—

Countries

Korea, Republic of

Contacts

Public Contactyoungjoo lee

National Cancer Center

Outcome results