280 Participants Needed

Reduced-Dose Chemotherapy for Lung Cancer

RR
Overseen ByRyan Romasko
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Fox Chase Cancer Center
Must be taking: Cytotoxic agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Is 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.56789

What 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.7891011

Research Team

JJ

Julia Judd, DO

Principal Investigator

Fox Chase Cancer Center

Eligibility 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.
See 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.
See 10 more

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

Treatment Details

Interventions

  • Carboplatin
  • Docetaxel
  • Gemcitabine
  • Irinotecan
  • Lurbinectedin
  • Nab paclitaxel
  • Paclitaxel
  • Pemetrexed
  • Topotecan
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Findings from Research

In a phase II trial involving 51 patients with untreated stage IIIB and IV non-small cell lung cancer, the combination of carboplatin and paclitaxel showed an overall response rate of 27.5%, indicating some effectiveness in treating this aggressive cancer.
The treatment was generally well-tolerated, with modest toxicity levels; only 5% of patients experienced severe nonhematologic side effects, suggesting that this combination therapy could be a safe option for further investigation.
Paclitaxel plus carboplatin for advanced lung cancer: preliminary results of a Vanderbilt University phase II trial--LUN-46.Johnson, DH., Paul, DM., Hande, KR., et al.[2015]
In a phase II trial involving 120 patients with extensive-stage small cell lung cancer, the combination of paclitaxel, carboplatin, and etoposide showed a significantly higher overall response rate of 78% compared to 48% for the paclitaxel and topotecan combination.
The paclitaxel-carboplatin-etoposide regimen also resulted in a longer median time to progression (7.6 months) compared to the paclitaxel-topotecan group (5.5 months), indicating it may be a more effective initial treatment option.
Paclitaxel/carboplatin/etoposide versus paclitaxel/topotecan for extensive-stage small cell lung cancer: a Minnie Pearl Cancer Research Network randomized, prospective phase II trial.Greco, FA., Thompson, DS., Morrissey, LH., et al.[2015]
The combination of docetaxel and cisplatin is effective for treating stage IIIB/IV non-small cell lung cancer, showing response rates between 32% and 48% and median survival times of 8 to 13 months across four phase II trials.
Docetaxel combined with carboplatin also demonstrated promising results, with a 48% response rate in a small group of 27 patients, indicating that these combinations are well tolerated and may improve outcomes if used earlier in the disease progression.
Docetaxel (Taxotere) in combination with platinum-based regimens in non-small cell lung cancer: results and future developments.Belani, CP.[2018]

References

Paclitaxel plus carboplatin for advanced lung cancer: preliminary results of a Vanderbilt University phase II trial--LUN-46. [2015]
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]
Docetaxel (Taxotere) in combination with platinum-based regimens in non-small cell lung cancer: results and future developments. [2018]
Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer. [2015]
Challenging the platinum combinations in the chemotherapy of NSCLC. [2022]
Docetaxel-based combined-modality chemoradiotherapy for locally advanced non-small cell lung cancer. [2019]
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: trial data and implications for clinical management. [2018]
Docetaxel (Taxotere) in combination with platinums in patients with non-small cell lung cancer: Trial data and implications for clinical management. [2019]
Docetaxel in combination with platinum compounds for non small-cell lung cancer. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel, carboplatin, and extended-schedule oral etoposide for small-cell lung cancer. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
Early phase studies with paclitaxel/low-dose carboplatin in patients with solid tumors. [2015]
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