Vitamin C with Chemotherapy and Radiation for Lung Cancer

(XACT-LUNG Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Joseph J. Cullen, MD, FACS

Must be taking: Carboplatin, Paclitaxel

Must not be taking: Warfarin, Flecainide

Disqualifiers: Recurrent cancer, G6PD deficiency, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide unless a substitution is possible. If you are on these medications and cannot switch, you may not be eligible to participate.

What data supports the effectiveness of the treatment involving Vitamin C with Chemotherapy and Radiation for Lung Cancer?

Research shows that combining paclitaxel and carboplatin with radiation therapy can improve local and systemic control of non-small cell lung cancer, potentially increasing survival rates. This combination has been found to be relatively safe and more active compared to some standard treatments. ^{1 2 3 4 5}

Is the combination of Vitamin C, chemotherapy, and radiation therapy safe for lung cancer treatment?

The combination of paclitaxel and carboplatin with radiation therapy has been found to be relatively safe and well-tolerated in patients with advanced non-small cell lung cancer, with manageable side effects. ^{1 2 3 5 6}

What makes the treatment of Vitamin C with chemotherapy and radiation for lung cancer unique?

This treatment is unique because it combines Vitamin C with standard chemotherapy drugs (carboplatin and paclitaxel) and radiation therapy, potentially enhancing the effectiveness of the chemotherapy and radiation by acting as a radiosensitizer, which may improve local and systemic control of the cancer. ^{1 2 3 4 5}

Research Team

Joseph J Cullen, MD, FACS

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults with non-small cell lung cancer who are healthy enough for chemotherapy and radiation, have a measurable tumor of at least 1 cm by CT or MRI, and not pregnant. They must have normal platelet counts and kidney function, no severe pleural effusion, no G6PD deficiency, not on certain medications like warfarin or insulin, and not HIV positive on antiretroviral therapy.

Inclusion Criteria

My kidney function tests are within the required range.

I have a small fluid collection in my chest that can't be safely removed and isn't seen on an X-ray.

The tumor or cancer spread needs to be at least 1 cm in size as seen on a CT scan.

Exclusion Criteria

Enrolled in another therapeutic clinical trial

I am taking one of the specified drugs and cannot or will not switch to a different one.

I have fluid buildup in the lining of my lungs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose ascorbate with standard chemotherapy and radiation therapy

10-12 weeks

3 visits per week (in-person)

Consolidation Chemotherapy

Participants receive 2 extra cycles of chemotherapy after combined therapy

6-8 weeks

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 6 months (in-person)

Long-term Follow-up

Participants have life-long follow-up for the study

Up to 20 years

Every 6 months (in-person)

Treatment Details

Interventions

• Ascorbic Acid (Other)
• Carboplatin (Alkylating agents)
• Paclitaxel (Anti-metabolites)
• Radiation Therapy (Radiation)

Trial Overview The study tests adding high-dose vitamin C (ascorbate) to the standard treatment regimen of carboplatin and paclitaxel chemotherapy combined with radiation therapy. All participants will receive this additional ascorbate alongside their prescribed treatments.

Participant Groups

Group I: ChemoRT + Ascorbate Experimental Treatment 4 Interventions

Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Holden Comprehensive Cancer Cener Iowa City, IA

Who Is Running the Clinical Trial?

Joseph J. Cullen, MD, FACS

Lead Sponsor

Trials

4

Patients Recruited

110+

National Institutes of Health (NIH)

Collaborator

Trials

2896

Patients Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Holden Comprehensive Cancer Center

Collaborator

Trials

27

Patients Recruited

710+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. Zhu, Y., Zhang, H., Hu, F.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial. Liang, J., Bi, N., Wu, S., et al.[2020]

Combination therapy using paclitaxel with carboplatin and radiation shows promise as a safer and more effective treatment for non-small cell lung cancer compared to the standard regimen of etoposide and cisplatin.

The use of paclitaxel, a novel taxane drug, in conjunction with radiation therapy may enhance local control of the cancer and improve overall response rates, suggesting a potential advancement in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent paclitaxel, carboplatin, and radiation therapy for locally advanced non-small cell lung cancer. Choy, H., Akerley, W., DeVore, RF.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporation of paclitaxel and carboplatin in combined-modality therapy for locally advanced non-small cell lung cancer. Belani, CP.[2015]

A systematic review of 31 studies involving 3090 patients treated with cisplatin-etoposide and 48 studies with 3728 patients treated with carboplatin-paclitaxel showed that both chemotherapy regimens had similar efficacy in treating unresectable stage III non-small-cell lung cancer, with no significant differences in overall survival or progression-free survival.

However, carboplatin-paclitaxel was associated with fewer severe hematological toxic effects compared to cisplatin-etoposide, making it a safer option for patients undergoing concurrent thoracic radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Concurrent Use of Thoracic Radiation With Either Carboplatin-Paclitaxel or Cisplatin-Etoposide for Patients With Stage III Non-Small-Cell Lung Cancer: A Systematic Review. Steuer, CE., Behera, M., Ernani, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction and concurrent paclitaxel/carboplatin every 3 weeks with thoracic radiotherapy in locally advanced non-small-cell lung cancer: an interim report. Movsas, B., Hudes, RS., Schol, J., et al.[2019]

References

1. China pubmed.ncbi.nlm.nih.gov

[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Concurrent paclitaxel, carboplatin, and radiation therapy for locally advanced non-small cell lung cancer. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Incorporation of paclitaxel and carboplatin in combined-modality therapy for locally advanced non-small cell lung cancer. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Concurrent Use of Thoracic Radiation With Either Carboplatin-Paclitaxel or Cisplatin-Etoposide for Patients With Stage III Non-Small-Cell Lung Cancer: A Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Induction and concurrent paclitaxel/carboplatin every 3 weeks with thoracic radiotherapy in locally advanced non-small-cell lung cancer: an interim report. [2019]