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Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Vitamin C

Tyrosine kinase inhibitor

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring tyrosine kinase inhibitor, Vitamin C, non-small cell lung cancer, progression-free survival, overall survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.
18 years old to 75 years old.
During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.
Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.
Expected survival over 3 months.
Household registration is Guangdong Province.

Exclusion Criteria:

Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).
Patients who are allergic to vitamin C.
Patients with HIV and other infectious diseases.
Patients who are taking anticoagulants and have coagulopathy;
Combine dysfunction of important organs such as heart, lung, liver and kidney;
Patients with impaired renal function (serum creatinine content > 1.2 mg/dL)
Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value.
Pregnant or lactating female.
Smoking and alcohol abuse patients;
Anti-infective treatment is required for systemic or localized serious infections;
Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));
Wilson's disease.
Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
History of surgery of visceral organs within 6 weeks before the study.

Sites / Locations

Clifford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental group

Control group

Arm Description

75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor.

75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)

Outcomes

Primary Outcome Measures

Progression free survival

From the start of treatment until the patient has tumor progression or death

Secondary Outcome Measures

Overall survival

The length of time from the start of treatment for a disease until death

Full Information

NCT ID

NCT03799094

First Posted

January 2, 2019

Last Updated

January 7, 2019

Sponsor

Clifford Hospital, Guangzhou, China

1. Study Identification

Unique Protocol Identification Number

NCT03799094

Brief Title

Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

Official Title

Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 5, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clifford Hospital, Guangzhou, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.

Detailed Description

The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated. This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process. Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

tyrosine kinase inhibitor, Vitamin C, non-small cell lung cancer, progression-free survival, overall survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Experimental

Arm Description

75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Other Intervention Name(s)

Sodium Ascorbate

Intervention Description

Participants will receive intravenous vitamin C therapy at the indicated dose.

Intervention Type

Drug

Intervention Name(s)

Tyrosine kinase inhibitor

Intervention Description

Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.

Primary Outcome Measure Information:

Title

Progression free survival

Description

From the start of treatment until the patient has tumor progression or death

Time Frame

From the start date of treatment until the date of first documented progression or death, assessed up to 2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

The length of time from the start of treatment for a disease until death

Time Frame

From the start date of treatment until the date of death from any cause, assessed up to 2 years.

Other Pre-specified Outcome Measures:

Title

Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30

Description

Using QLQ-C30: Function subscales, (include physical, role, emotional, cognitive, social, global) (averaged, 0-100, higher value represent a better outcome); Symptoms subscales (include fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) (averaged, 0-100, lower value represent a better outcome). Given at basal, 1, 2, 3, 6, 12 months.

Time Frame

From the start date of treatment until the date of first documented progression or death, assessed up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21. 18 years old to 75 years old. During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time. Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2. Expected survival over 3 months. Household registration is Guangdong Province. Exclusion Criteria: Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis. Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication). Patients who are allergic to vitamin C. Patients with HIV and other infectious diseases. Patients who are taking anticoagulants and have coagulopathy; Combine dysfunction of important organs such as heart, lung, liver and kidney; Patients with impaired renal function (serum creatinine content > 1.2 mg/dL) Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value. Pregnant or lactating female. Smoking and alcohol abuse patients; Anti-infective treatment is required for systemic or localized serious infections; Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h)); Wilson's disease. Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent. Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery; History of surgery of visceral organs within 6 weeks before the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junwen Ou, PhD

Phone

86-13556021810

oujunwen66@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junwen Ou, PhD

Organizational Affiliation

Clifford Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Clifford Hospital

City

Guangzhou

ZIP/Postal Code

511495

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junwen Ou, PhD

Phone

86-13556021810

oujunwen66@163.com

First Name & Middle Initial & Last Name & Degree

Junwen Ou, PhD

12. IPD Sharing Statement

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Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

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