Carboplatin Before Surgery for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+131 other locations
Overseen byHeather H Cheng
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Southwest Oncology Group
Disqualifiers: Metastatic disease, Prior pelvic RT, Other malignancy, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on certain prostate cancer treatments like gnRH agonists or anti-androgens, you can continue them if their effects don't last beyond one month after joining the study.
What data supports the effectiveness of the drug carboplatin before surgery for prostate cancer?
Research shows that carboplatin has moderate activity in treating prostate cancer, with 17% of patients experiencing a partial response and 50% having disease stabilization. Additionally, carboplatin is known to be effective in other cancers like ovarian and breast cancer, and it is less toxic than similar drugs like cisplatin.
12345Is carboplatin generally safe for humans?
Carboplatin is generally considered safe for humans, with milder side effects compared to similar drugs like cisplatin. It does not cause kidney damage at normal doses and is less likely to cause nerve or hearing problems. However, it can cause a decrease in blood cells, which may lead to increased risk of infection or bleeding.
678910How is the drug carboplatin unique in treating prostate cancer?
Carboplatin is unique in treating prostate cancer because it is a platinum-based drug that is less toxic than its predecessor, cisplatin, and is being explored for use before surgery to potentially improve outcomes. It is typically used in combination with other drugs for patients who have already been heavily treated with other therapies.
111121314Eligibility Criteria
This trial is for men over 18 with high-risk prostate cancer and a BRCA1 or BRCA2 gene mutation. They should have advanced cancer (stage cT3a - cT4x, Gleason sum 8-10) and a PSA level over 20 ng/mL. Participants can be on certain hormone treatments but must not extend beyond one month after joining the study.Inclusion Criteria
My prostate cancer is high grade (Gleason score 8-10).
My cancer is classified between stages cT3a to cT4x.
I can take care of myself and am up and about more than 50% of my waking hours.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive carboplatin intravenously before undergoing surgery
6-8 weeks
Surgery
Participants undergo surgery after receiving neoadjuvant carboplatin
1 week
Follow-up
Participants are monitored for PSA progression and other outcomes post-surgery
Up to 5 years
Participant Groups
The trial is testing if giving Carboplatin, a platinum-containing chemotherapy drug, before surgery can shrink tumors in patients with high-risk prostate cancer who also carry the inherited BRCA gene mutations.
1Treatment groups
Experimental Treatment
Group I: Treatment (carboplatin)Experimental Treatment7 Interventions
Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial.
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:
PeaceHealth Saint John Medical CenterLongview, WA
Yale-New Haven Hospital North Haven Medical CenterNorth Haven, CT
Saint Alphonsus Cancer Care Center-BoiseBoise, ID
Saint Luke's Cancer Institute - MeridianMeridian, ID
More Trial Locations
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Who Is Running the Clinical Trial?
Southwest Oncology GroupLead Sponsor
SWOG Cancer Research NetworkLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Overview of carboplatin: replacing, complementing, and extending the therapeutic horizons of cisplatin. [2018]Carboplatin is the one platinum analogue that has received widespread clinical testing both in cancers that are normally targets for cisplatin and in others. It was introduced in 1981 because of its lesser toxicity and equivalent biochemical selectivity and antitumor spectrum relative to cisplatin in preclinical systems. Clinical studies have generally confirmed these expectations and given rise to interesting prospects in current cancer therapeutics. Carboplatin is as effective as cisplatin in ovarian cancer and considerably less toxic. Replacement of cisplatin by carboplatin seems likely in a number of other diseases where cisplatin has played a major role, especially if ongoing phase III studies confirm the regimens are equivalent. Carboplatin may also complement cisplatin's role by its innovative integration into treatment strategies, and by use of it as additional treatment when cisplatin's nonhematologic toxicities are prohibitive. Finally, although it is not likely to possess a different therapeutic spectrum than cisplatin, carboplatin appears to be extending the indications for platinum compounds to new areas such as acute leukemia, endometrial cancer, and breast cancer. In the latter, use of autologous bone marrow reconstitution permits the dose intensity needed for promising therapeutic results. Carboplatin has become the experimental platinum analogue of choice in a wide range of new clinical situations and in combinations with other modalities.
A phase II study of pemetrexed and carboplatin in patients with locally advanced or metastatic breast cancer. [2015]Pemetrexed and carboplatin have demonstrated activity in breast cancer. Their potential synergism in experimental models and the proven efficacy of pemetrexed/platinum in other indications make pemetrexed/carboplatin an attractive combination in breast cancer. Thus, this two-stage, sequential, open-label, multicenter, phase II study assessed the efficacy and safety of pemetrexed plus carboplatin as first-line therapy in patients with locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
[Development of carboplatin]. [2013]Carboplatin (CBDCA; commercial name: Paraplatin) is a platinum complex having 1-cyclobutanedicarboxylic acid group at the two chlorine positions of cisplatin (CDDP). In the preclinical studies, CBDCA was proved to be almost equally effective to various murine tumors compared to cisplatin. Compared to cisplatin, of which free platinum was not detected from 2 hr after administration, the free type of more than 85% of total platinum concentration remained in the blood even 8 hrs after administration. Total urine excretion at 2-4 hrs after administration of CBDCA was about 57-82%, indicating CBDCA's relative rapid urine excretion compared to CDDP. In the clinical trials in Japan, appreciable clinical responses were observed in head and neck, small cell lung, ovarian, uterine cervical cancers, testicular tumor and malignant lymphoma. The renal toxicity was considerably slight, resulting in almost no hydration during treatment. Nausea and vomiting were also slight and there were no hearing-loss and neurotoxicities. The dose-limiting factor (DLF) in the phase I study was myelosuppression. From these results, it was found that carboplatin's antitumor efficacies were almost identical with cisplatin and much less toxic than cisplatin. Carboplatin will serve as a useful antitumor drug in current cancer chemotherapy.
Carboplatin in advanced hormone refractory prostatic cancer patients. [2019]25 patients with measurable or evaluable metastatic prostate cancer, progressive after hormonal treatment, were treated weekly with carboplatin 150 mg/m2 intravenously. The weekly schedule allowed higher dose intensity carboplatin administration with respect to the common monthly cycles. Toxicity was manageable even in elderly patients with extensive bone metastases and consisted primarily of myelosuppression. 4 out of 24 evaluable patients (17%) had a partial response and 12 (50%) had disease stabilisation. The median response duration was 7 months. Prostate-specific antigen and prostatic acid phosphatase serial values showed a correlation with disease response in only 47 and 50% of patients, respectively. These results suggest that carboplatin possesses a moderate but definite activity in prostate cancer patients.
Phase II trial of preoperative pemetrexed plus carboplatin in patients with stage IB-III nonsquamous non-small cell lung cancer (NSCLC). [2019]The combination of pemetrexed and carboplatin is a standard first-line treatment for patients with advanced NSCLC. In this pilot phase II trial, we evaluated the feasibility of using pemetrexed and carboplatin as neoadjuvant therapy, prior to definitive surgical resection, for patients with localized NSCLC.
Probable cutaneous hypersensitivity to carboplatin single-agent chemotherapy in a dog. [2013]Carboplatin is usually a well-tolerated drug and has many applications in veterinary oncology. The side effects of carboplatin described in the veterinary literature include myelotoxicity, nephrotoxicity, digestive and appetite disorders. In 114 dogs treated by single-agent chemotherapy with carboplatin, we observed a rate of non-haematological toxicities of 19·3% (personal observation). This case report describes the first case of cutaneous delayed-hypersensitivity to carboplatin in a dog, diagnosed according to the official ABON-system, which determines a causal association between a suspected product and a reported reaction (A=probable, B=possible, O=unclassifiable and N=unlikely), and an experimental intradermal skin test. Antihistamines were used to treat the reaction, and future carboplatin treatments were adjusted by premedication with corticosteroids, prolonged infusion and a reduction of 20% of the first dose of carboplatin. No further reactions were noted during the following treatments.
Single-agent carboplatinum for advanced seminoma. A phase II study. [2019]To reduce the side effects of cisplatin-based combination chemotherapy, the activity of carboplatinum was evaluated in patients with advanced seminoma.
[A case of advanced seminoma treated effectively with single agent carboplatin therapy]. [2013]Cisplatin has played a major role in the treatment of germ cell tumors. However, it causes renal damage, severe nausea and vomiting. It is also neurotoxic and ototoxic. Carboplatin is an analog of cisplatin which, does not cause renal damage at therapeutic doses. It is not neurotoxic or ototoxic and it produces less gastrointestinal toxicity than cisplatin. We used carboplatin alone as an initial chemotherapy in a 36-year-old man with stage IIB seminoma. Following left radical orchiectomy the patient received 4 courses of carboplatin chemotherapy. After the first course of chemotherapy, tumor markers (LDH, beta-HCG) returned to the normal range. After 4 courses, the size of the retroperitoneal metastases was significantly reduced. The toxicity of 4 courses of carboplatin chemotherapy was generally milder than that of cisplatin-based combination chemotherapies such as PVB or VAB-6. There were no episodes of septicemia, thrombocytopenic bleeding or renal deterioration. The patient did not suffer from alopecia, neuropathy, symptomatic hearing loss, severe nausea or vomiting. Nine months after the completion of carboplatin chemotherapy, the patient remains well and free from disease progression. This case strongly suggests that single agent carboplatin therapy could be an effective and less-toxic treatment for advanced seminoma.
Platinum analogue combination chemotherapy: cisplatin and carboplatin--a phase I trial with pharmacokinetic assessment of the effect of cisplatin administration on carboplatin excretion. [2017]Cisplatin (NSC 119875) and carboplatin (NSC 241240) are platinum (II) analogues with very different spectra of toxicity. Cisplatin dose is limited by nausea and vomiting, renal dysfunction, and dose-related peripheral neuropathy, whereas carboplatin is myelosuppressive. There are also clinical and laboratory data that suggest that these drugs may not be completely cross-resistant. Therefore, the following phase I trial of combination therapy with cisplatin and carboplatin was undertaken. Since carboplatin toxicity is enhanced in the presence of renal impairment, carboplatin excretion was also evaluated in selected patients at the maximum tolerated dose. Thirty-three patients received 50 mg/m2 cisplatin and doses of carboplatin between 160 mg/m2 and 400 mg/m2. Sequential 20-minute infusions of carboplatin and then cisplatin were able to be administered at the standard doses of carboplatin (320 and 400 mg/m2) with thrombocytopenia to the degree expected if carboplatin alone had been given. However, 280 mg/m2 carboplatin followed by 25 mg/m2 cisplatin/d X 3 caused unexpectedly severe thrombocytopenia in seven of eight patients (median platelet nadir 45,000/microL; range, 12 to 321,000/microL; nadir was less than 90,000 in seven of eight patients). In three patients treated with 280 mg/m2 carboplatin plus 25 mg/m2/d X 3 cisplatin, pharmacokinetics of carboplatin were compared during consecutive monthly cycles without and with cisplatin. Modestly increased areas under the curve (AUC) for carboplatin (15% and 35%) with cisplatin were seen in the two patients who experienced more pronounced platelet suppression with combination therapy. No other limiting or unusual toxicity was seen with this combination. Responses, primarily in "platinum responsive" tumors, were seen. The combination of cisplatin plus carboplatin is feasible and merits further study.
Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis. [2020]Platinum-based chemotherapy is the mainstay of first-line (1L) therapy for advanced non-small cell cancer (NSCLC). The objective of this study was to evaluate the relative efficacy, safety, and health-related quality of life (HRQoL) of carboplatin- versus cisplatin-based chemotherapy in 1L NSCLC.
Carboplatin plus etoposide in heavily pretreated castration-resistant prostate cancer patients. [2014]Carboplatin plus etoposide has modest efficacy in docetaxel-pretreated castration-resistant prostate cancer patients. We hypothesized that carboplatin-etoposide could still exert some therapeutic activity after docetaxel, cabazitaxel and either abiraterone or enzalutamide.
The role of carboplatin in combination with paclitaxel in patients with castration-resistant prostate cancer. [2023]Background: The aim of the present study was to examine the efficacy of carboplatin in combination with paclitaxel in patients with metastatic castration-resistant prostate cancer pretreated with multiple regimens including docetaxel and androgen receptor-targeted agents. Methods: Clinical data from patients treated with carboplatin plus paclitaxel were collected retrospectively from a single institution. Results: 43 patients with metastatic castration-resistant prostate cancer were identified. Median number of cycles was ten (range: 1 to 23), prostate-specific antigen response was observed in 18 (42%) patients, median progression-free survival was 115 days and median overall survival was 8.1 months. Conclusion: Combination chemotherapy using taxane with carboplatin is an effective and well-tolerated therapy in heavily pretreated patients with metastatic castration-resistant prostate cancer.
Carboplatin in the treatment of oesophageal cancer. [2014]Cisplatin has modest activity in squamous cancer of the oesophagus but substantial toxicity limits its usefulness. Carboplatin (Paraplatin; BM Group), a second-generation platinum analogue, was developed to maintain the antitumour activity of cisplatin and reduce toxicity. Eleven patients with advanced oesophageal cancer were treated with carboplatin. A partial response was seen in 1 patient (9%) and minor responses in 2 cases. The median survival was 12 months in responding patients and 3 months in non-responders. One patient suffered reversible myelosuppression but nephrotoxicity and vomiting were not observed. Carboplatin is well tolerated and may have a role as a less toxic substitute for cisplatin in combination chemotherapy regimens for oesophageal cancer.
A phase II study of carboplatin in children with recurrent or progressive solid tumors. A report from the Childrens Cancer Group. [2019]Carboplatin is an analogue of cisplatin with less nonhematologic toxicity than the parent compound. It has been demonstrated previously to have activity against a spectrum of pediatric brain tumors. This Phase II study was undertaken to assess the activity of carboplatin in children with various solid tumors.