Paclitaxel for Gastric Cancer

Overseen By Brian D Badgwell

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Infections, Pregnancy, Heart failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests paclitaxel to determine the optimal dose and understand its side effects for individuals with stomach or gastroesophageal cancer. Paclitaxel, a type of chemotherapy, stops cancer cell growth. The trial targets those diagnosed with adenocarcinoma in the stomach or at the junction of the stomach and esophagus, with cancer that has metastasized. Participants should have completed some chemotherapy before joining. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage cancer research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that paclitaxel is generally safe for patients with advanced stomach cancer. Studies have found that its side effects are usually mild and manageable. For instance, one study found that paclitaxel, when combined with another drug, has real-world data supporting its safety compared to other treatments.

This trial is a Phase 1 study, focusing on safety and determining the best dose. Although specific safety data for this trial is limited, the drug's use in other studies is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Paclitaxel is unique because it's a chemotherapy drug that interferes with the normal function of microtubule breakdown in cancer cells, effectively preventing cell division. Unlike standard treatments for gastric cancer, which often involve a combination of surgery and other chemotherapy drugs like fluorouracil or cisplatin, paclitaxel offers a targeted approach with a different mechanism of action. Researchers are excited about paclitaxel because it can be administered weekly in a relatively short infusion time, potentially leading to fewer side effects and improved patient tolerance. This could mean better quality of life for patients undergoing treatment and possibly more effective management of gastric cancer.

What evidence suggests that paclitaxel might be an effective treatment for gastric cancer?

Research has shown that paclitaxel, the treatment under study in this trial, is a promising option for stomach cancer. Studies have found it can help control the disease in about half of the patients who use it. In some cases, paclitaxel helped patients live longer without their cancer worsening. This drug stops cancer cells from growing and dividing, which can shrink tumors. While not every patient responds the same way, these findings suggest that paclitaxel may benefit those with advanced stomach cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Brian Badgwell, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with gastric or gastroesophageal cancer who have good physical function (ECOG <=2) and adequate blood counts. They must have completed preoperative chemotherapy, not be pregnant or breastfeeding, agree to use contraception, and can't have severe heart conditions, active infections, or life-threatening reactions to similar chemo drugs.

Inclusion Criteria

My cancer is confirmed to be in the stomach or where the stomach meets the esophagus.

My cancer has spread to the lining of my abdomen.

Absolute neutrophil count >= 1,500/uL

Exclusion Criteria

I can follow the study's requirements and attend all follow-up visits.

I have severe heart issues, like unstable chest pain or significant heart failure.

I've had surgery that makes it unsafe to have a diagnostic laparoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive paclitaxel intraperitoneally over 1 hour once weekly during weeks 1-3 and 5-7

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel

Trial Overview The study is testing different doses of Paclitaxel to find the safest and most effective amount for treating stomach and gastroesophageal cancers. It's a phase I trial focused on understanding side effects while trying to stop cancer cell growth by killing them or stopping their spread.

How Is the Trial Designed?

Group I: Treatment (paclitaxel) Experimental Treatment 1 Intervention

Patients receive paclitaxel IP over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in European Union as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

Paclitaxel is an effective treatment for treatment-refractory ovarian cancer, working by stabilizing microtubules to induce cytotoxicity, despite facing challenges like severe hypersensitivity reactions and formulation issues.

The drug is associated with significant side effects, including myelosuppression, mucositis, and neurotoxicity, which are dose-dependent, highlighting the need for careful management in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (taxol). Kohler, DR., Goldspiel, BR.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5759614/

Nab-paclitaxel as second-line treatment in advanced ... Indeed, the administration of nab-paclitaxel resulted in an ORR of 23.1% and a disease control rate of 51.3%; moreover, the mPFS reached 3.0 months, and the mOS ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949752324000025

Efficacy and safety of nab-paclitaxel chemotherapy for ... Nab-paclitaxel mono-chemotherapy is an effective treatment option for previously treated and recurrent gastric cancer with a manageable toxicity profile.

3. esmogastro.org esmogastro.org/article/S2949-8198(24)00034-7/fulltext

Real-world efficacy and toxicity data of paclitaxel and ... Real-world efficacy and toxicity data of paclitaxel and ramucirumab compared with other treatment regimens in patients with advanced gastric cancer

4. ar.iiarjournals.org ar.iiarjournals.org/content/37/5/2715

Initial Experience with Nab-Paclitaxel for Patients ... This study has demonstrated three important findings. First, nab-paclitaxel is safe for second- or later-line chemotherapy for advanced/recurrent gastric cancer ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.442

A randomized, open-label, non-inferiority phase 3 trial. Conclusions: Paclitaxel oral solution demonstrated non-inferiority in PFS and superiority in OS compared to paclitaxel IV, with clinically ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.282

A multicenter randomized phase III study of albumin-bound ... The aim of this study was to evaluated the efficacy and safety of AS and SOX in the first-line treatment of advanced gastric cancer.