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.12345
Is the combination of Vitamin C, chemotherapy, and radiation therapy safe for lung cancer treatment?
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.12345
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.
See 6 more
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.
See 8 more
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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: ChemoRT + AscorbateExperimental Treatment4 Interventions
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Holden Comprehensive Cancer CenerIowa City, IA
Loading ...
Who Is Running the Clinical Trial?
Joseph J. Cullen, MD, FACSLead Sponsor
National Institutes of Health (NIH)Collaborator
National Cancer Institute (NCI)Collaborator
Holden Comprehensive Cancer CenterCollaborator
References
[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]Based on superior results with combined-modality therapy in patients with advanced,unresectable non-small cell lung cancer (NSCLC),to evaluate the activity and toxicity of combination of paclitaxel with carboplatin and concurrent radiation therapy.
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]The optimal chemotherapy regimen administered currently with radiation in patients with stage III non-small cell lung cancer (NSCLC) remains unclear. A multicenter phase III trial was conducted to compare the efficacy of concurrent thoracic radiation therapy with either etoposide/cisplatin (EP) or carboplatin/paclitaxel (PC) in patients with stage III NSCLC.
Concurrent paclitaxel, carboplatin, and radiation therapy for locally advanced non-small cell lung cancer. [2015]Combination chemotherapy plus radiation therapy for non-small cell lung cancer has several theoretical advantages: the potential of chemotherapy to radiosensitize tumors, the possibility of improved local control due to combined treatment, and the opportunity for spatial cooperation, attacking disease both locally and systemically and thus potentially increasing response and, ultimately, survival. The combination of radiotherapy plus standard chemotherapy (etoposide plus cisplatin) has yielded limited success; therefore, new and novel chemotherapies have been sought. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), the prototype of a novel class of drugs, the taxanes, has proven feasible both alone and with other agents in combined-modality regimens with radiation. Concurrent paclitaxel/carboplatin/radiotherapy appears to offer a relatively safe and more active regimen to control local and metastatic non-small cell lung cancer than the current standard. This report reviews the range of experience with paclitaxel-based combined-modality therapy.
Incorporation of paclitaxel and carboplatin in combined-modality therapy for locally advanced non-small cell lung cancer. [2015]Combined chemotherapy and thoracic radiation therapy has emerged as a primary treatment option for locally advanced, unresectable non-small cell lung cancer (NSCLC). Randomized trials and subsequent metaanalyses have shown a clear survival benefit with platinum-based combination chemotherapy administered sequentially or concurrently with hyperfractionated thoracic radiation over radiation alone. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin recently have been evaluated in numerous phase 1/11 trials at various doses in both sequential and concurrent schedules with thoracic radiation in patients with locally advanced and unresectable NSCLC. The patterns of failure in patients treated with concurrent paclitaxel/carboplatin and thoracic radiation suggest the need for additional chemotherapy either at the front end or after completion of the concurrent regimen. A large multicenter randomized study (Locally Advanced Multimodality Protocol) has been initiated to address these issues of improvement in distant control and to further refine the combined-modality approach for patients with locally advanced NSCLC. Several other combined-modality regimens incorporating a platinum compound and a novel agent like gemcitabine, vinorelbine, paclitaxel, or docetaxel have been recently completed or are in progress. The hope for the immediate future is to define an "effective" and "optimal" regimen that can be given simultaneously with thoracic radiation and can result in improved local and systemic control in patients with regionally advanced NSCLC. Numerous phase II and III trials are currently planned or under way to further define the efficacy of this novel combination of paclitaxel/carboplatin in combined-modality programs in an attempt to determine the optimal administration sequence of chemotherapy and thoracic radiation. These combined-modality programs are now being integrated into trials for early stage, potentially resectable disease. Thus, NSCLC is in fact a systemic disease requiring a multidisciplinary approach for optimal management.
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]The 2 most common chemotherapy regimens used concurrently with thoracic radiation for patients with unresectable IIIA and IIIB non-small-cell lung cancer (NSCLC) are carboplatin-paclitaxel and cisplatin-etoposide. There are no prospective comparisons of these 2 regimens in this setting.
Induction and concurrent paclitaxel/carboplatin every 3 weeks with thoracic radiotherapy in locally advanced non-small-cell lung cancer: an interim report. [2019]The paclitaxel/carboplatin combination has demonstrated promising activity in metastatic non-small-cell lung cancer (NSCLC); therefore, we mounted an exploratory study of these agents with thoracic radiation (TRT) in locally advanced NSCLC. Eligibility stipulated a Karnofsky performance status >or= 70%, weight loss or= 2 esophagitis has corresponded to length (> 16 cm) of esophagus in the radiation treatment field (Fisher's exact test, P = 0.006). The partial response rate to induction therapy was 40% and to the combined modality therapy was 60%. The median survival for all 49 patients is 15.3 months, with a median disease-free survival (DFS) of 7.8 months. In the subset of 22 patients treated on the phase I portion of the study, the median survival and DFS were 18.5 months and 13.5 months, respectively. Induction therapy with paclitaxel and carboplatin followed by concurrent chemoradiotherapy with the same agents is an active and well-tolerated treatment approach in locally advanced NSCLC. To date, paclitaxel 175 mg/m2 plus carboplatin AUC 5 administered at 3-week intervals for 2 cycles is safe in combination with TRT.