Topotecan for Small Cell Lung Cancer

(Drug-SNP Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Must be taking: Topotecan

Must not be taking: Other anti-cancer therapies

Disqualifiers: Pneumonectomy, Pregnancy, Serious illness, 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: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Topotecan for treating small cell lung cancer (SCLC). Researchers aim to understand how changes in specific genes influence Topotecan's effectiveness and potential side effects. Two groups will receive different forms of the drug to compare results. Individuals diagnosed with SCLC who can undergo a lung tissue biopsy may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who cannot stop other anti-cancer therapies. It's best to discuss your specific medications with the trial team.

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

Research has shown that topotecan is generally well-tolerated by patients with small cell lung cancer. Studies have found that while it can cause side effects, these are usually mild and manageable with standard care. For instance, a real-world study observed patients taking topotecan and noted that although some experienced side effects, they were often mild and manageable.

Another study compared topotecan to a different drug and found that topotecan's safety was considered manageable. This means that while side effects might occur, they typically do not require stopping treatment.

In summary, extensive studies have shown that topotecan is generally safe for patients, though monitoring for side effects remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of Topotecan for Small Cell Lung Cancer because it offers a unique approach compared to the standard chemotherapy treatments like cisplatin and etoposide. Unlike these common drugs, Topotecan is derived from camptothecin and works by inhibiting an enzyme called topoisomerase I, which is crucial for DNA replication in cancer cells. This mechanism can potentially overcome resistance seen in other treatments and provide an alternative for patients who have not responded well to existing options. Additionally, the trial includes a study group using a China Import Topotecan Capsule, which might offer different pharmacokinetics or accessibility benefits.

What evidence suggests that Topotecan might be an effective treatment for small cell lung cancer?

Research has shown that topotecan may help treat small cell lung cancer (SCLC), particularly in patients whose cancer has returned after initial treatment. In this trial, participants will receive either the usual approach with topotecan or a study approach with a China Import Topotecan Capsule. Studies indicate that patients using topotecan have a median survival time of about 25 weeks, similar to other treatments like the CAV chemotherapy regimen. The response rate, which measures how often the cancer shrinks or stops growing, is about 13.6%. This suggests that topotecan might help control the disease for some patients. Overall, while it may not significantly extend life, it can be a useful option for managing SCLC symptoms. ^{4 6 7 8 9}

Who Is on the Research Team?

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IRB00009424 - IORG0007849

HAN ID XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Are You a Good Fit for This Trial?

This trial is for individuals with small cell lung cancer. It's focused on how changes in specific genes might affect the way a cancer drug, Topotecan, works and what side effects it may cause.

Inclusion Criteria

I have been diagnosed with Small Cell Lung Cancer.

Random and double blind

Sign an informed consent form

Exclusion Criteria

Treatment with other anti-cancer therapies and cannot be stopped currently

Pregnancy

Breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Chemotherapy with Topotecan Capsule and undergo SNP genotyping to explore therapeutic efficacy and safety

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Topotecan

Trial Overview

The study looks at two things: if gene variations related to the target of Topotecan influence its effectiveness against cancer, and if different gene versions related to drug processing affect side effects.

How Is the Trial Designed?

Group I: Topotecan - usual Experimental Treatment 1 Intervention

* Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group

Group II: Topotecan - study Experimental Treatment 1 Intervention

* China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group

Who Is Running the Clinical Trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

6

Recruited

2,400+

UnitedHealthcare

Collaborator

Trials

5

Recruited

594,000+

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK56815/

The clinical effectiveness and cost-effectiveness of topotecan ...

The aim of this systematic review and economic evaluation was to assess the clinical effectiveness and cost-effectiveness of topotecan as second-line treatment ...

2.

nature.com

nature.com/articles/srep15437

Topotecan for Relapsed Small-cell Lung Cancer

Chemotherapy-related death 2% (95% CI: 1–3%). In conclusion, Topotecan provided a possibly promising outcome for sensitive-relapse SCLC and poor ...

3.

publications.ersnet.org

publications.ersnet.org/content/erj/27/6/1183

Efficacy of a toxicity-adjusted topotecan therapy in recurrent ...

Median survival was 25 weeks for topotecan and 24.7 weeks for CAV. The present study demonstrated that topotecan has significant advantages in controlling ...

4.

eviq.org.au

eviq.org.au/medical-oncology/respiratory/small-cell-lung-cancer/377-sclc-advanced-topotecan-modified

Small cell lung cancer advanced topotecan (modified)

Median survival duration was 25.0 weeks with topotecan and 24.7 weeks with CAV(P=.795). Topotecan was shown to be as effective as CAV and was more effective ...

5.

mdpi.com

mdpi.com/2075-4418/14/14/1572

Topotecan in a Real-World Small-Cell Lung Cancer Cohort

In our cohort, the response rate was 13.6%, median PFS was 1.9 months, and median OS was 5.6 months and thus are in line with survival results found in the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11276225/

Topotecan in a Real-World Small-Cell Lung Cancer Cohort

Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: An open-label multicenter ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03554473

M7824 and Topotecan or Temozolomide in Relapsed ...

Safety data from the dose-escalation study in solid tumors as well as preliminary data from expansion cohorts show that M7824 has a safety profile similar to ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e20576

Efficacy and safety of second-line (2L) therapy in patients ...

Relapsed SCLC patients treated with currently approved treatments have poor survival outcomes, especially those with resistant disease.

9.

tlcr.amegroups.org

tlcr.amegroups.org/article/view/88422/html

Comparative efficacy and safety of anlotinib and topotecan as ...

Anlotinib shows significantly better progression-free survival compared to topotecan in patients with relapsed SCLC, with a manageable safety profile.