Rhenium Re 188 P2045 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 & 2
Recruiting
Sponsor: Andarix Pharmaceuticals
Disqualifiers: Diabetes, Hypertension, Bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called Rhenium Re 188 P2045 on lung cancer patients. It aims to find a safe dose and check if it helps reduce tumors. Patients are monitored closely for side effects and tumor response.
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 coordinators or your doctor.
What makes the drug Rhenium Re 188 P2045 unique for lung cancer treatment?
Rhenium Re 188 P2045 is unique because it involves a radioactive isotope, Rhenium-188, which is not commonly used in standard lung cancer treatments. This drug may offer a novel approach by directly targeting cancer cells with radiation, potentially providing a different mechanism of action compared to traditional chemotherapy drugs.12345
Eligibility Criteria
This trial is for adults with advanced or recurrent lung cancer (NSCLC or SCLC) who have seen their disease progress after chemotherapy, or those who refused standard chemo. They must have a measurable tumor that hasn't been treated with radiation, or one that has grown significantly if previously irradiated.Inclusion Criteria
My lung cancer is advanced, recurrent, or has spread.
My cancer has worsened after chemotherapy or I chose not to undergo standard chemotherapy.
My tumor is at least 1 cm big in a non-radiated area or has grown 50% in a radiated area.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive escalating doses of Rhenium Re 188 P2045 to determine the maximum tolerated dose
4 weeks
Multiple visits for dose administration and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Regular visits for safety assessments and tumor progression analysis
Treatment Details
Interventions
- Rhenium Re 188 P2045 (Radioisotope Therapy)
Trial OverviewThe study is testing the safety of different doses of an experimental drug called Rhenium Re 188 P2045 in lung cancer patients. The goal is to find the highest dose patients can take without serious side effects by starting low and gradually increasing.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00100256Iowa City, IA
NCT00100256Baltimore, MD
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Who Is Running the Clinical Trial?
Andarix PharmaceuticalsLead Sponsor
References
Establishment of the standard regimen for non-small-cell lung cancer in Japan. [2018]Preclinical data suggest that irinotecan (Camptosar, CPT-11), a novel topoisomerase I inhibitor, has exhibited promising activity in the treatment of lung cancer. In a phase II study of non-small-cell lung cancer, irinotecan demonstrated a 32% response rate. Combinations of irinotecan and cisplatin (Platinol) have also demonstrated synergistic activity against non-small-cell lung cancer. A phase I trial of irinotecan combined with cisplatin in previously untreated non-small-cell lung cancer patients showed an encouraging response rate of 54%, with irinotecan at 60 mg/m2 on days 1, 8, and 15, plus cisplatin at 80 mg/m2. In a phase II study of chemotherapy-naive patients with stage IIIB/IV non-small-cell lung cancer, irinotecan/cisplatin yielded a response rate of 52% and a mean survival time of 44 weeks. Data from a phase III trial comparing cisplatin at 80 mg/m2 on day 1 plus vindesine at 3 mg/m2 on days 1, 8, and 15 with two irinotecan-containing regimens--cisplatin at 80 mg/m2 on day 1 plus irinotecan at 60 mg/m2 on days 1, 8, and 15, and single-agent irinotecan at 100 mg/m2 on days 1, 8, and 15--have also been reported. Responses were observed in 32%, 44%, and 21% of patients for the vindesine/cisplatin, irinotecan/cisplatin, and irinotecan arms, respectively, with corresponding median survival times of 45.6, 50.0, and 46.0 weeks; there were no significant differences in response rate or survival between treatment groups for all patients. However, subset analysis of stage IV patients indicated a significant survival advantage for irinotecan/cisplatin; the median survival time was 50 weeks for patients receiving irinotecan/cisplatin, 36.4 weeks for vindesine/cisplatin, and 42.1 weeks for irinotecan (P = .004 for the irinotecan/cisplatin arm vs vindesine/cisplatin; P = .018 for irinotecan vs vindesine/cisplatin). Another phase III study compared irinotecan/cisplatin and vindesine/cisplatin. There was no difference in overall median survival time, and the median survival times were not significantly different for stage IV patients in the respective irinotecan/cisplatin and vindesine/cisplatin arms (44.7 vs 45.3 weeks). Further studies are needed to determine whether irinotecan/cisplatin combinations improve survival in comparison with other promising platinum-containing regimens.
Triplet combination chemotherapy and targeted therapy regimens. [2005]Current agents for the treatment of non-small-cell lung cancer include gemcitabine (Gemzar), paclitaxel (Taxol), docetaxel (Taxotere), vinorelbine (Navelbine), and irinotecan (CPT-11, Camptosar). Experimental agents include pemetrexed (LY231514, Alimta) and tirapazamine. Molecular and biological therapies include angiogenesis inhibitors, epidermal growth factor receptor inhibitors, HER2/neu inhibitors, and inhibitors of ras activation and function. Doublet chemotherapy is currently the standard treatment for advanced non-small-cell lung cancer. In the past 2 years, randomized trials have shown that many of the new two-drug combinations used to treat non-small-cell lung cancer have equivalent efficacy. These combinations produce 1-year survival rates of about 35% and 2-year survival rates of about 15%. Toxicity rates vary but are sufficiently low as to make the development of three-drug combinations feasible. Preliminary studies from several phase I and II trials suggest that triplet therapy can improve survival beyond that of double therapy regimens.
The treatment of non-small cell lung cancer: current perspectives and controversies, future directions. [2007]The projected cure rate for patients who develop lung cancer in 1993 is only 13%. The majority of these patients have metastatic disease at the time of diagnosis, and are therefore ineligible for curative surgery. Among the minority of patients who undergo surgical therapy with curative intent, the majority experience relapse in metastatic sites. Patients with metastatic disease cannot be cured with currently available therapies. Recent randomized studies suggest that cisplatin-based chemotherapy regimens can prolong survival in patients with metastatic non-small cell lung cancer and small cell lung cancer. It was thus logical to evaluate cisplatin-based chemotherapy in early disease stages. Many randomized studies have compared radiation therapy alone with radiation plus cisplatin-based chemotherapy in locally advanced, inoperable, stages IIIA and IIIB non-small cell lung cancer. Most, but not all, of these studies show a survival benefit for the combined-modality approach. Although the improvement in median length of survival in these studies is modest, long-term survival rates are often doubled or tripled. The optimal chemoradiotherapy combination is unknown. Fewer randomized trials have evaluated cisplatin-based chemotherapy as an adjuvant to surgery in operable stages I through IIIA disease. A trial of the Lung Cancer Study Group comparing postoperative cyclophosphamide/doxorubicin/cisplatin with immunotherapy in stages II and IIIA adenocarcinoma and large cell carcinoma showed a small survival advantage for the chemotherapy. A European postoperative randomized study comparing cisplatin-based chemotherapy with no therapy also showed a survival advantage for chemotherapy, as did a small ongoing study from M.D. Anderson Cancer Center (Houston, TX) with preoperative chemotherapy. However, there are many negative randomized studies evaluating postoperative chemotherapy, especially with non-cisplatin-based regimens, and further studies are obviously needed. Many new agents have produced exciting preliminary results. Response rates in excess of 20% were reported for paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), irinotecan (CPT-11), topotecan, and gemcitabine. Studies in the next few years will help to define the ultimate role of these agents. Further developments in understanding the biology (and molecular biology) of lung cancer are leading to preclinical studies of antigrowth factors and genetic therapy.
First- and second-line therapy for advanced nonsmall cell lung cancer. [2018]The objectives for the treatment of advanced nonsmall cell lung cancer are palliative and include improvement of survival, symptom control, quality of life and cost. The level of evidence of these benefits is based on multiple randomised trials and meta-analyses. Cisplatin-based chemotherapy with one of the regimens shown to be effective should be preferred. Carboplatin may be substituted for cisplatin if medical contraindications exist. Nonplatinum-based regimens are indicated as first-line treatment for advanced nonsmall cell lung cancer in patients for whom platinum-based chemotherapy is contraindicated. Single drug chemotherapy may be considered in patients with poor performance status. The choice of the active drugs depends on the patient's medical condition. There is no conclusive evidence that high doses of cisplatin (100-120 mg.m(-2)) provide better results than standard lower doses (50-60 mg.m(-2)) in terms of survival. The optimal duration of chemotherapy is poorly documented in advanced nonsmall cell lung cancer. A minimum of four to six cycles is advised in responding patients. Second-line chemotherapy is now accepted as a standard and should be offered to patients with good performance status and failing platinum-based first-line chemotherapy. Evidence is in favour of docetaxel and in the case of adenocarcinoma and adequate renal function, pemetrexed is recommended.
Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer. [2019]Cisplatin-based chemotherapy is the standard adjuvant therapy for patients with completely resected stage II or III non-small cell lung cancer (NSCLC). However, the completion rate of four cycles of cisplatin-based chemotherapy is about 50%. This phase II study was conducted to evaluate the tolerability and efficacy of nedaplatin and irinotecan as adjuvant chemotherapy.