Topotecan for Small Cell Lung Cancer
(Drug-SNP Trial)
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.12345Why 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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Chemotherapy with Topotecan Capsule and undergo SNP genotyping to explore therapeutic efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Topotecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Lead Sponsor
UnitedHealthcare
Collaborator