A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC

Phase 2Active Not RecruitingNCT02905591

Joseph J. Cullen, MD, FACS43 enrolled

Overview

This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.

For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy." This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm. Participants will: * receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered. * undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays. * provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need. However, it is very important the investigators remain in contact with participants; they will have life-long follow-up for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer Non-Small-Cell Lung Carcinoma NSCLC

Interventions

Radiation TherapyDRUG

Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days

PaclitaxelDRUG

Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered * the dose is 45 mg/m2 (standard dose) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standardized dose reductions are used

CarboplatinDRUG

Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done. * Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard) * Administered weekly * 6 to 7 weeks of therapy, depending on when radiation starts * Standard dose reductions are used

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible * Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer. * Recommended to receive carboplatin \& paclitaxel with radiation therapy as a treatment * Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan) * Physician determined the patient is healthy enough for chemotherapy and radiation therapy * At least part of the lung cancer must be viewable and measurable by CT or MRI * A platelet count of at least 100,000 cells per mililiter * A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2) * Not pregnant, and commit to using birth control during the study Exclusion Criteria: * Exudative pleural effusion * Recurrent non-small cell lung cancer * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Patients actively receiving insulin or patients whose doctors have recommended current insulin use * Patients requiring daily finger-stick blood glucose measurements * Patients who are on the following drugs and cannot have a substitution or who decline the substitution: * warfarin * flecainide * methadone * amphetamines * quinidine * chlorpropamide * Prior radiation therapy that would result in a field overlap * Enrolled in another therapeutic clinical trial * Uncontrolled, intercurrent illness * Lactating women * HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.

Locations (1)

Holden Comprehensive Cancer Cener

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Progression Rate at the Completion of Radiation and Chemotherapy

The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.

Time frame: 3 to 4 weeks after last radiation treatment

Secondary Outcomes

Tumor Response

From radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.

Time frame: Every six months for up to 20 years post-treatment

Progression Free Survival (PFS)

Time, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression

Time frame: Every six months for up to 20 years post-treatment

Overall Survival (OS)

Time, measured in months, from start of radiation to death from any cause.

Time frame: Every three months for up to 20 years post-treatment

Adverse Event Frequency and Categorization

Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows: * Through radiation, weekly assessment of adverse events * Consolidation chemotherapy, assessment day 1 of each cycle * Post-treatment, every 6 months through 2 years post-therapy

Time frame: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment

Data from ClinicalTrials.gov

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