Abraxane + Gemcitabine for Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Muhammad Furqan

Must not be taking: Corticosteroids, Taxanes

Disqualifiers: Pregnancy, Heart disease, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Up to 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the combination of Abraxane (a type of chemotherapy) and Gemcitabine (also known as Gemzar, another chemotherapy) can treat small cell lung cancer that has worsened after initial treatment. The goal is to assess the effectiveness of these drugs when used together. The trial seeks patients with small cell lung cancer that has returned or spread after initial treatment. Those who have been treated for small cell lung cancer before and experienced progression despite first-line chemotherapy may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must wait at least 21 days after your last chemotherapy and 2 weeks after your last targeted or immunotherapy before starting the trial treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of nab-paclitaxel (Abraxane) and gemcitabine has been studied for safety in various cancer types. One study found that this combination led to positive results in patients with relapsed or difficult-to-treat small cell lung cancer.

Patients generally tolerate this treatment well. However, like most cancer treatments, it can cause side effects. Common side effects include tiredness, low blood cell counts, and nausea. Serious side effects are less common but can occur. Patients should discuss these risks with their doctor.

These findings suggest that nab-paclitaxel and gemcitabine together have a manageable safety profile for many patients. Staying in touch with healthcare providers is crucial to monitor any side effects during treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

Researchers are excited about the combination of Nab-paclitaxel and Gemcitabine for small cell lung cancer because it offers a new approach compared to the standard chemotherapy options like cisplatin and etoposide. Nab-paclitaxel, a novel formulation of paclitaxel, uses tiny protein particles to deliver the drug directly to the cancer cells, potentially improving its effectiveness while reducing side effects. Gemcitabine is known for disrupting the DNA replication in cancer cells, and when paired with Nab-paclitaxel, it could enhance the overall anti-cancer effects. This combination aims to provide a more targeted treatment with the potential for better outcomes and fewer side effects, making it a promising option for patients.

What evidence suggests that Abraxane and Gemcitabine could be effective for small cell lung cancer?

In this trial, participants will receive a combination of gemcitabine and nab-paclitaxel. A previous study showed promising results for patients with relapsed or hard-to-treat small cell lung cancer (SCLC). This combination led to better outcomes by shrinking tumors and delaying cancer progression. Research has shown that nab-paclitaxel can enhance treatment effectiveness and prolong the time before cancer progresses, especially in patients who have previously undergone chemotherapy. While these findings are encouraging, results can vary from person to person. ^{2 3 6 7 8}

Who Is on the Research Team?

Muhhamad Furqan, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

Adults over 18 with small cell lung cancer that's come back after one treatment can join. They need good organ function, no major surgery or brain metastasis symptoms recently, and must not be pregnant or nursing. Participants should agree to use contraception and have measurable cancer growth per specific criteria.

Inclusion Criteria

My kidney function is normal, based on my creatinine levels.

I finished my main radiation therapy 2 weeks ago or my palliative radiation 48 hours ago.

My liver tests are within the required limits.

Exclusion Criteria

I haven't had active cancer, except for certain skin, prostate, cervix, breast, or bladder cancers, in the last year.

My brain metastasis is stable, and I haven't needed steroids for at least 7 days.

I am not allergic to albumin-bound paclitaxel or gemcitabine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nab-Paclitaxel and Gemcitabine on Days 1 and 8 of a 21-day cycle until disease progression, unacceptable toxicity, or withdrawal

Up to 3 years

Visits on Days 1 and 8 of each 21-day cycle

Follow-up

Participants are monitored for overall survival and progression-free survival every 3 months until death or study completion

Up to 3 years

Evaluations every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab-paclitaxel

Trial Overview The trial is testing the effectiveness of combining two chemotherapy drugs, Abraxane (Nab-paclitaxel) and Gemcitabine, in treating relapsed small cell lung cancer. Patients previously treated but now showing progression are eligible for this combination therapy.

How Is the Trial Designed?

Group I: Nab-Paclitaxel with Gemcitabine Experimental Treatment 2 Interventions

Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Muhammad Furqan

Lead Sponsor

Trials

5

Recruited

130+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322450/

Phase II study of nab-paclitaxel with gemcitabine for ... Our study showed that the combination of gemcitabine and nab-paclitaxel led to encouraging outcomes in relapsed/refractory SCLC.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35393247/

Phase II Trial of Combination Nab-paclitaxel and ... Combination nab-paclitaxel and gemcitabine after platinum and pemetrexed for NSQ-NSCLC was not associated with greater efficacy than would be expected for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023091119

Efficacy and safety of nanoparticle albumin-bound ... Nab-paclitaxel enhances OR, PR, PFS, and marginally improves OS in advanced NSCLC, particularly in patients with prior chemotherapy.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.e21035

A phase II trial of albumin-bound paclitaxel and ... A phase II trial of albumin-bound paclitaxel and gemcitabine in patients with newly diagnosed PD-L1 IHC low/unknown stage IV squamous cell lung cancers.

5. abraxanepro.com abraxanepro.com/advanced-non-small-cell-lung-cancer

ABRAXANE® for Advanced Non-Small Cell Lung Cancer Learn about tumor response, efficacy, and dosing data on ABRAXANE® + carboplatin for 1L advanced or metastatic NSCLC. See full prescribing info and BOXED ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660490/

Efficacy and safety of nanoparticle albumin-bound paclitaxel ... Nab-paclitaxel enhances OR, PR, PFS, and marginally improves OS in advanced NSCLC, particularly in patients with prior chemotherapy.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1303268/full

Phase II study of nab-paclitaxel with gemcitabine for ... Our study showed that the combination of gemcitabine and nab-paclitaxel led to encouraging outcomes in relapsed/refractory SCLC.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02027428

Safety and Efficacy Study of Abraxane as Maintenance ... Maintenance treatment of advanced stage squamous cell NSCLC. Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive ...