Reduced-Dose Chemotherapy for Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Fox Chase Cancer Center
Must be taking: Cytotoxic agents
Must not be taking: Targeted agents, Immunotherapy
Disqualifiers: Gastrointestinal obstruction, Uncontrolled illness, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, stable doses of anti-seizure medications are allowed if your CNS disease is treated and stable. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination used in the Reduced-Dose Chemotherapy for Lung Cancer trial?
Research shows that the combination of paclitaxel and carboplatin has been effective in treating non-small cell lung cancer, with response rates up to 48% and 1-year survival rates as high as 54%. Additionally, the combination of docetaxel and carboplatin has shown promising activity with a 48% response rate, indicating potential effectiveness for lung cancer treatment.
12345Is reduced-dose chemotherapy for lung cancer safe for humans?
Docetaxel, when combined with other drugs like cisplatin or carboplatin, is generally well-tolerated in treating lung cancer. The main side effect is neutropenia (a drop in white blood cells), but severe nerve damage and kidney problems are uncommon. Other combinations with docetaxel, such as with gemcitabine or irinotecan, also show manageable side effects, making these treatments generally safe for humans.
56789What makes the reduced-dose chemotherapy treatment for lung cancer unique?
The reduced-dose chemotherapy treatment for lung cancer is unique because it combines multiple drugs like Carboplatin, Docetaxel, and others, potentially reducing side effects while maintaining effectiveness. This approach may offer a better balance between treatment efficacy and tolerability compared to standard-dose regimens.
7891011Eligibility Criteria
This trial is for adults over 18 with stage IV lung cancer (small cell or non-small cell) or inoperable stage III. They may have had previous treatments and can have stable, treated brain metastases. Participants must be able to perform daily activities (ECOG 0-3), not be pregnant, agree to use contraception, and plan to receive one of the listed chemotherapy drugs.Inclusion Criteria
I am older than 18 years.
I am a man who will use birth control during and 6 months after the study.
I have brain metastases but don't need steroids, had no recent brain radiation, and if on seizure meds, my condition is stable.
+9 more
Exclusion Criteria
I have another cancer, but it won't affect this trial's treatment.
Pregnant or breast feeding.
My cancer has spread to the lining of my brain and spinal cord.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive dose attenuated chemotherapy regimens based on their comorbidities and age
First four cycles with dose modifications
Regular visits as per chemotherapy cycle schedule
Follow-up
Participants are monitored for safety, efficacy, and progression-free survival
6 years
Open-label extension (optional)
Participants may continue to receive treatment and be monitored long-term
Long-term
Participant Groups
The study tests lower doses of common chemotherapy drugs like Carboplatin and Paclitaxel in patients with other health issues. It's an open-label phase II trial, meaning everyone gets treatment and researchers know what's given. The goal is to see how well patients tolerate these reduced doses while monitoring effectiveness.
3Treatment groups
Experimental Treatment
Group I: Single agent chemotherapy with or without a VEGFiExperimental Treatment10 Interventions
Group II: Platinum doublet with or without a VEGFiExperimental Treatment10 Interventions
Group III: Platinum doublet plus immunotherapy (IO)Experimental Treatment10 Interventions
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:
Fox Chase Cancer CenterPhiladelphia, PA
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Who Is Running the Clinical Trial?
Fox Chase Cancer CenterLead Sponsor
References
Paclitaxel plus carboplatin for advanced lung cancer: preliminary results of a Vanderbilt University phase II trial--LUN-46. [2015]Based on their good activity and minimal toxicity in non-small cell lung cancer and other cancers, we initiated a phase II trial of carboplatin plus paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in the treatment of patients with previously untreated stage IIIB and IV non-small cell lung cancer. Among 51 patients treated, the overall response rate was 27.5% (14 partial responses). Seventeen patients had stable disease, while 16 patients experienced disease progression after two cycles of treatment. Apart from myelosuppression, toxicity has been modest, with fewer than 5% of patients experiencing grade 3 or greater nonhematologic toxicity. Objective response and survival rates were modestly improved among patients given the higher of two paclitaxel doses (175 mg/m2 v 135 mg/m2). These data suggest that paclitaxel plus carboplatin warrants further study in metastatic non-small cell lung cancer.
Paclitaxel/carboplatin/etoposide versus paclitaxel/topotecan for extensive-stage small cell lung cancer: a Minnie Pearl Cancer Research Network randomized, prospective phase II trial. [2015]To compare the combination of paclitaxel (Taxol; Bristol-Myers Squibb, Princeton, NJ, http://www.bms.com) and topotecan (Hycamtin; Glaxo SmithKline, Philadelphia, http://www.gsk.com) with paclitaxel, carboplatin (Paraplatin; Bristol-Myers Squibb), and etoposide (Etopophos, VePesid; Bristol-Myers Squibb) in patients with previously untreated extensive-stage small cell lung cancer.
Docetaxel (Taxotere) in combination with platinum-based regimens in non-small cell lung cancer: results and future developments. [2018]The combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) with cisplatin is feasible, has manageable toxicity, and is active in stage IIIB/IV non-small cell lung cancer. The four phase II trials completed to date show response rates ranging from 32% to 48% and median survival durations of 8 to 13 months. Based on these results, regimens combining 75 to 100 mg/m2 docetaxel with 75 to 100 mg/m2 cisplatin are now being assessed in randomized phase III comparisons with platinum-containing combinations. The combination of docetaxel and carboplatin also has promising activity, with response rates of 48% (1 complete response and 12 partial responses) seen in 27 evaluable patients. Overall, this combination is also well tolerated. However, it will be necessary to use both docetaxel/platinum regimens at earlier stages in the disease if a significant impact is to be made on survival.
Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer. [2015]Chemotherapeutic intervention in advanced and metastatic non-small-cell lung cancer (NSCLC) has changed over the past 2 decades. The improvements offered by cisplatin (Platinol)-based regimens, though significant in terms of survival and quality of life, were modest at best. Carboplatin (Paraplatin), which possesses a toxicity profile favorable to that of its parent analogue cisplatin, yielded survival rates superior to that of the cisplatin-combination chemotherapy arms in a large randomized study of patients with metastatic non-small-cell lung cancer. With the introduction of taxanes in the early 1990s, paclitaxel (Taxol) demonstrated single-agent activity of 21% to 24%, with a 40% 1-year survival rate in metastatic disease. The next generation of phase I/II studies evaluated the efficacy of paclitaxel in combination with carboplatin. Results with this regimen have shown substantial promise, and 1-year survival rates as high as 54% have been reported. Full doses of both agents have been combined without any additional toxicity, and there appears to be a dose-response effect with paclitaxel. The combination of paclitaxel and carboplatin has been incorporated as the investigational arm of all the ongoing multicenter and cooperative group studies. While the results from these randomized studies are awaited, this combination has become the most widely used regimen in community practice for patients with non-small-cell lung cancer. It is also being evaluated for treatment at earlier disease stages, in the setting of minimal tumor burden, and in combined-modality regimens.
Challenging the platinum combinations in the chemotherapy of NSCLC. [2022]In previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) the combination of docetaxel and gemcitabine is active and well tolerated. In the phase II setting using a 3-week schedule, response rates (RR) ranged from 25 to 50%, and median survival from 11 to 13 months. Preliminary data with weekly and bi-weekly schedules indicate maintained efficacy while reducing the risk of neutropenia. A randomized phase III trial has shown that the combination of docetaxel and gemcitabine is as active as docetaxel plus cisplatin, achieving a 1-year survival rate of 39%, with significantly less neutropenia and gastro-intestinal toxicity. The combination of docetaxel with vinorelbine is equally active and the associated toxicities are manageable. In phase II studies the average response rate is 40%, and in one study using a 2-week schedule the 1-year survival rate was 60%. With this combination neutropenia is the commonest adverse event while clinically significant neuropathy is infrequent. In a randomized phase II trial, docetaxel plus cisplatin was compared to docetaxel plus irinotecan. The non-platinum doublet achieved comparable levels of activity, though with a different toxicity profile (more diarrhea but less nausea and vomiting). The combination of docetaxel with irinotecan and carboplatin has achieved 1-year survival of 55%. All three docetaxel combinations (gemcitabine, vinorelbine, and irinotecan) could provide a valuable alternative to platinum-based chemotherapy and should be further evaluated in phase III setting.
Docetaxel-based combined-modality chemoradiotherapy for locally advanced non-small cell lung cancer. [2019]The cytotoxic agent docetaxel not only has proven activity in non-small cell lung cancer-when used alone or in combination-but is also a potent radiosensitizer, and improved treatments are needed in all stages of this disease. In patients with locoregionally advanced (stage III) disease, docetaxel has shown efficacy with manageable toxicities when used alone or in combination with a platinum compound in a sequential manner before localized radical radiotherapy/surgery. Presently, therapeutic gains appear to be maximized by the use of concurrent chemotherapy and irradiation. This review focuses on research with combinations of docetaxel with either cisplatin or carboplatin and radiotherapy. Overall response and survival rates to date provide data worth pursuing. From phase I data, weekly docetaxel at 20 mg/m(2) plus cisplatin at 25 mg/m(2) or carboplatin to an area under the concentration time curve of 2 mg/ml*min with concurrent radiotherapy to 60 Gy over 6 weeks appear to be suitable for phase II trials. Predominant toxicities are esophagitis and neutropenia, but a low frequency of pulmonary toxicity is reported. Induction, concurrent, and consolidation docetaxel-based chemoradiotherapy in potentially resectable disease are all being investigated. Future research could include the investigation of computed tomography/ positron emission tomography-derived target volume radiotherapy, dose-escalated therapy, and alternative fractionation schedules in combination with docetaxel-based cytotoxic chemotherapy.
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: trial data and implications for clinical management. [2018]Docetaxel (Taxotere; Aventis, Antony, France) is among the most effective agents for the treatment of non-small cell lung cancer and its use in combination with cisplatin is a logical development. Docetaxel has been combined with cisplatin and is well-tolerated with promising activity in phase II studies. Extensive phase II investigations in the first-line setting recorded response rates of 32% to 52% survival (median, 8 to 12 months) with 33% to 48% of patients alive at 1 year. Neutropenia is dose-limiting. However, the incidence of severe neuropathy is low and clinically significant nephrotoxicity is uncommon. Following these encouraging findings, the combination of docetaxel with cisplatin has been studied in two randomized phase III trials that compare the new combination against reference regimens. These studies have completed accrual and data are expected shortly. The combination of docetaxel with carboplatin is also active and feasible. Neutropenia is the main adverse event and grade II or III neurotoxicity is uncommon. In phase II trials combining doses of 65 to 100 mg/m2 docetaxel with doses of carboplatin designed to maintain an area under the curve of 5 to 7.5 mg/mL/min, response rates have ranged from 30% to 67%.
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: Trial data and implications for clinical management. [2019]Docetaxel (Taxotere; Aventis, Antony, France) is among the most effective agents for the treatment of non-small cell lung cancer and its use in combination with cisplatin is a logical development. Docetaxel has been combined with cisplatin and is well-tolerated with promising activity in phase II studies. Extensive phase II investigations in the first-line setting recorded response rates of 32% to 52% survival (median, 8 to 12 months) with 33% to 48% of patients alive at 1 year. Neutropenia is dose-limiting. However, the incidence of severe neuropathy is low and clinically significant nephrotoxicity is uncommon. Following these encouraging findings, the combination of docetaxel with cisplatin has been studied in two randomized phase III trials that compare the new combination against reference regimens. These studies have completed accrual and data are expected shortly. The combination of docetaxel with carboplatin is also active and feasible. Neutropenia is the main adverse event and grade II or III neurotoxicity is uncommon. In phase II trials combining doses of 65 to 100 mg/m2 docetaxel with doses of carboplatin designed to maintain an area under the curve of 5 to 7.5 mg/mL/min, response rates have ranged from 30% to 67%.
Docetaxel in combination with platinum compounds for non small-cell lung cancer. [2019]Assessing the combination of docetaxel with cisplatin or carboplatin was based on their activity as single agents, their nonoverlapping toxicity profiles, and their lack of cross-resistance. Phase I studies of docetaxel in combination with cisplatin established that 75 mg/m2 of each agent could be administered with reasonable safety and appeared to be active in non small-cell lung cancer (NSCLC). We evaluated the docetaxel/cisplatin combination in patients with advanced NSCLC. The response rate was 32%, and the median survival was 11.5 months. Efficacy was comparable to that observed in the Australian and French trials with the same combination. This is now being evaluated further in two large randomized trials for patients with advanced NSCLC and has been incorporated into the combined modality programs for early-stage disease. Carboplatin, devoid of the nephrotoxicity and neurotoxicity associated with the parent cis-platin, was then combined with docetaxel. The recommended dose of docetaxel for further evaluation in combination with carboplatin (AUC=6 mg/mL.min) was 90 mg/m2 with filgrastim support and 80 mg/m2 without filgrastim support. Our phase II trial of the combination of docetaxel and carboplatin in advanced NSCLC demonstrated an overall response rate of 36%; median survival was 13.9 months, and 1-year survival was 52%. Comparable activity has been seen by other investigators, and the regimen is being evaluated in two randomized trials. The combination of docetaxel with either of the two platinum agents has reasonable activity in NSCLC, though the carboplatin/docetaxel doublet appears to have a better therapeutic index.
Paclitaxel, carboplatin, and extended-schedule oral etoposide for small-cell lung cancer. [2015]We evaluated the feasibility and efficacy of combination paclitaxel (Taxol) (via 1-hour infusion), carboplatin (Paraplatin), and oral etoposide (VePesid) in the first-line treatment of patients with small-cell lung cancer. Between June 1993 and July 1996, 117 patients with small-cell lung cancer. were treated in two sequential phase II studies. The first 38 patients received a lower-dose regimen: paclitaxel 135 mg/m2, via 1-hour infusion; carboplatin dosed to an area under the concentration-time curve (AUC) of 5.0, and oral etoposide 50 mg alternating with 100 mg on days 1 through 10. Based on a very favorable toxicity profile, the paclitaxel and carboplatin doses were increased in the subsequent cohort of 79 patients (paclitaxel 200 mg/m2 by 1-hour infusion; carboplatin target AUC increased to 6.0). Thoracic radiation therapy (1.8 Gy/day; total dose, 45 Gy) was administered concurrently with courses 3 and 4 of chemotherapy in patients with limited-stage small-cell lung cancer. The combination of paclitaxel 200 mg/m2, carboplatin to an AUC of 6.0, and extended-schedule oral etoposide 50 or 100 mg alternating days 1 through 10 is highly active and well tolerated in patients with small-cell lung cancer. The regimen can be administered concurrently with radiation therapy with no unusual side effects, although a minority of patients develop esophagitis. Median survival rates in patients with both extensive- and limited-stage disease compare favorably with other reported regimens.
Early phase studies with paclitaxel/low-dose carboplatin in patients with solid tumors. [2015]In preparation for the design of phase II studies in lung cancer, low-dose carboplatin, fixed at a target area under the concentration-time curve (AUC) of 4.0 or 4.5 mg x min/mL, has been combined with escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in a series of studies to establish the maximum tolerated dose of the combination. In patients who had received prior chemotherapy, the maximum tolerated paclitaxel dose was 135 mg/m2 (carboplatin target AUC 4.0); the dose-limiting toxicity was febrile neutropenia. Without granulocyte colony-stimulating factor support in chemotherapy-naive patients (carboplatin target AUC 4.5), and with granulocyte colony-stimulating factor in chemotherapy-pretreated patients, the current paclitaxel dose is 290 mg/m2. The maximum tolerated dose has not been defined. In a study in which paclitaxel was given by 1-hour infusion with carboplatin (target AUC 4.5), a 205 mg/m2 dose was poorly tolerated. No evidence of pharmacokinetic interactions between paclitaxel and carboplatin was found. Twenty-one evaluable patients with lung cancer have been treated to date. There have been two partial responses, one minor response, and 10 patients with stable disease at paclitaxel doses of 100 to 270 mg/m2.