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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if combining two chemotherapy drugs, Abraxane and Gemcitabine, can treat small cell cancer that has come back or spread after initial treatment. The treatment is for patients whose cancer did not respond to the first round of therapy. The drugs work by stopping cancer cells from growing and spreading. Gemcitabine has been used with other drugs for various cancers, showing positive results in some cases.

Research Team

Muhhamad Furqan, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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