Papaverine + Chemoradiation for Lung Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Must be taking: Chemotherapy
Disqualifiers: Pneumonectomy, Scleroderma, Pulmonary fibrosis, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This phase I trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.
What data supports the effectiveness of the drug combination of Papaverine, Carboplatin, and Paclitaxel with radiation therapy for lung cancer?
Research shows that combining Paclitaxel and Carboplatin with radiation therapy can improve survival in patients with advanced non-small cell lung cancer. Paclitaxel is known to enhance the effect of radiation, making it a valuable part of this treatment approach.
12345Is the combination of paclitaxel, carboplatin, and radiation therapy generally safe for humans?
Research shows that the combination of paclitaxel, carboplatin, and radiation therapy is generally safe for treating certain cancers, like cervical and lung cancer. Side effects can include mild gastrointestinal issues and skin reactions, but severe side effects are rare.
12678What makes the Papaverine + Chemoradiation treatment for lung cancer unique?
This treatment combines papaverine, a drug that may enhance the effects of radiation, with standard chemotherapy drugs carboplatin and paclitaxel, and radiation therapy. The inclusion of papaverine is novel, as it is not commonly used in lung cancer treatment, potentially improving the effectiveness of radiation therapy.
3591011Eligibility Criteria
Adults with stage II-III non-small cell lung cancer that hasn't spread beyond the original site and is considered inoperable. Participants must have a life expectancy over 6 months, be well enough for chemotherapy with radiation, and not have had certain other cancers or treatments within specific time frames. They should also not be pregnant or breastfeeding and agree to use contraception.Inclusion Criteria
Your hemoglobin level has to be at least 9 grams per deciliter within 30 days before joining the study.
I am 18 years old or older.
My lung cancer is confirmed to be non-small cell type.
+20 more
Exclusion Criteria
I have liver problems causing yellowing of my skin or eyes and issues with blood clotting.
I haven't had chemotherapy or targeted therapy for over 2 years.
I have a history of scleroderma or idiopathic pulmonary fibrosis.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants receive papaverine in combination with chemoradiation for 6 weeks
6 weeks
5 visits per week (in-person)
Immunotherapy
Patients with PD-L1 positive disease receive durvalumab every 2 weeks for 12 months
12 months
Bi-weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Visits at 1, 3, 6, 9, 12, 16, 20, and 24 months, then periodically up to 5 years
Participant Groups
The trial is testing the effectiveness of papaverine combined with chemoradiation therapy (using carboplatin and paclitaxel) on patients with non-small cell lung cancer. Papaverine aims to slow down cancer growth by targeting mitochondrial metabolism.
1Treatment groups
Experimental Treatment
Group I: Treatment (papaverine, RT, paclitaxel, carboplatin)Experimental Treatment6 Interventions
Patients receive PPV IV or SC and undergo 5 fractions of RT per week. Patients also receive paclitaxel IV over 1 hour and carboplatin IV QW over 1-6 weeks or pemetrexed IV over 10 minutes followed by carboplatin IV every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning 1 month of completing CRT, patients with PD-L1 positive disease receive durvalumab IV Q2W for 12 months.
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:
City of HopeDuarte, CA
Ohio State University Comprehensive Cancer CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
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 chemoradiotherapy for advanced cervical cancer--a pilot study]. [2013]Recently, attempts have made to use radiotherapy in combination with chemotherapy in various solid tumors including cervical cancer. Twenty-four patients with locally advanced cervical cancer were treated with concurrent Carboplatin (16-24 mg/m2/day) or Nedaplatin (20 mg/m2/week) and conventional radiotherapy. Of 13 evaluable patients, there were nine complete responders and four partial responders. There was no renal damage or grade 4 hematological toxicity. Gastrointestinal adverse reactions were mild. One patient had grade 3 dermatologic toxicity after delayed radiation therapy. This pilot study suggests that daily Carboplatin or weekly Nedaplatin administered with standard radiation therapy is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer.
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.
A phase I/II study of paclitaxel (TAXOL) and concurrent radiotherapy in advanced nonsmall cell lung cancer. [2019]The addition of chemotherapy to radical radiotherapy (XRT) has been shown to improve survival in locally advanced nonsmall cell lung cancer (9). Consequently, different chemotherapeutic regimens in combination with XRT are being evaluated in the treatment of this disease. Paclitaxel (TAXOL) may be a valuable drug in this situation as, in addition to a demonstrated activity in NSCLC, it has been shown to enhance the effect of radiation on cell lines in vitro.
A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). [2019]We conducted a prospective phase II study to determine the response rate, toxicity, and survival rate of concurrent weekly paclitaxel, carboplatin, and hyperfractionated radiation therapy (paclitaxel/carboplatin/HFX RT) followed by 2 cycles of paclitaxel and carboplatin for locally advanced unresectable non-small cell lung cancer (NSCLC). The weekly paclitaxel and carboplatin regimen was designed to optimize the radiosensitizing properties of paclitaxel during the concurrent phase of treatment.
Phase I clinical trial of weekly paclitaxel, weekly carboplatin, and concurrent radiotherapy for primary cervical cancer. [2015]Standard primary treatment for locally advanced cervix cancer is radiation (RT) with concomitant platinum-based chemotherapy (CT). Incomplete local control and the appearance of distant disease herald poor survival and warrant evaluation of new primary strategies. Paclitaxel and carboplatin are active agents in recurrent cervical carcinoma, have potent, synergistic in vitro radiosensitization, and are cytotoxic in weekly schedules. This study was done to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly paclitaxel/carboplatin chemoradiotherapy in locally advanced cervix cancer.
[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.
Five-year outcomes of adjuvant carboplatin/paclitaxel chemotherapy and intravaginal radiation for stage I-II papillary serous endometrial cancer. [2019]The purpose of this study is to report our single-institution experience with concurrent adjuvant intravaginal radiation (IVRT) and carboplatin/paclitaxel chemotherapy for early stage uterine papillary serous carcinoma (UPSC).
Phase I study with weekly cisplatin-paclitaxel and concurrent radiotherapy in patients with carcinoma of the cervix uteri. [2020]Cisplatin and paclitaxel are active in cervical cancer and both are able to potentiate the effects of radiotherapy. In this study we evaluated the maximum-tolerated dose (MTD) of paclitaxel in combination with a fixed dose of cisplatin when given weekly concurrently with pelvic radiotherapy to patients with carcinoma of the cervix uteri.
A randomized phase III adjuvant study in high-risk cervical cancer: simultaneous radiochemotherapy with cisplatin (S-RC) versus systemic paclitaxel and carboplatin followed by percutaneous radiation (PC-R): a NOGGO-AGO Intergroup Study. [2023]Simultaneous adjuvant platinum-based radiochemotherapy in high-risk cervical cancer (CC) is an established treatment strategy. Sequential paclitaxel (Taxol) and platinum followed by radiotherapy may offer further advantages regarding toxicity.
Scheduling of chemotherapy and radiotherapy in locally advanced non-small cell lung cancer. [2019]In scheduling chemotherapy and radiotherapy for locally advanced non-small cell lung cancer (NSCLC), chemotherapy can be given pre-radiotherapy or concurrently as a single agent or in combination. Optimal scheduling has yet to be established. Optimal pre-radiotherapy for NSCLC requires further development but cisplatin with vinblastine, vindesine, etoposide or navelbine appear the best currently available. A number of new drugs show potential for enhancing radiation effects. Concurrent chemotherapy and radiotherapy has been tested in a number of experimental tumours in cell culture. In these systems cisplatin, carboplatin, 5-fluorouracil, mitomycin-C and other agents appear to improve cell kill compared to chemotherapy alone. Mouse xenograft models allow the study of various concurrent drug and radiation schedules including the effect of radiation with cisplatin, carboplatin, paclitaxel and gemcitabine. In these systems, cisplatin in divided doses shows optimal enhancement with fractionated radiotherapy. There are a number of drug candidates for concurrent chemotherapy and radiotherapy programs. Clinical studies in head and neck cancer, esophageal cancer, small cell lung cancer and NSCLC show promising results with concurrent chemotherapy and radiotherapy. Cisplatin given daily with radiotherapy improved survival in NSCLC compared to cisplatin given weekly with radiotherapy or to radiotherapy alone. To study the toxicity of radiation and concurrent carboplatin, we have studied 170 patients with unresectable locally advanced NSCLC in a 4-arm randomized trial. An analysis of the first 100 patients entered revealed significantly more neutropenia (P