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

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of paclitaxel for the treatment of gastric or gastroesophageal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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.

What data supports the effectiveness of the drug Paclitaxel for gastric cancer?

Research shows that Paclitaxel, when combined with another drug called cisplatin, has shown promising results in treating advanced gastric cancer, especially in patients who did not respond to other treatments. Additionally, a study comparing Paclitaxel to another drug, irinotecan, found it to be a viable option for patients with advanced gastric cancer. ^{1 2 3 4 5}

Is paclitaxel safe for humans?

Paclitaxel has been used in various cancer treatments and is generally considered safe, though it can cause side effects like low white blood cell counts (neutropenia), nerve damage (neurotoxicity), allergic reactions, and changes in heart rhythm. These side effects are often related to the dose and schedule of the treatment. ^{1 6 7 8 9}

How is the drug paclitaxel unique for treating gastric cancer?

Paclitaxel is unique for treating gastric cancer because it has shown promising activity and can be combined with other drugs like carboplatin and cisplatin to enhance its effectiveness, especially in patients who have not responded to standard treatments like 5-fluorouracil and platinum. It works by inducing apoptosis (programmed cell death) in cancer cells, which is a different mechanism compared to some other treatments. ^{1 2 4 9 10}

Research Team

Brian Badgwell, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase II trial of low-dose paclitaxel and cisplatin in patients with advanced gastric cancer. [2015]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

A phase II study of paclitaxel and cisplatin as salvage therapy for patients with advanced or metastatic gastric cancer. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Absence of beta-tubulin gene mutation in gastric carcinoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Machine-learning model derived gene signature predictive of paclitaxel survival benefit in gastric cancer: results from the randomised phase III SAMIT trial. [2022]

6. United States 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). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An early phase II study of a 3-hour infusion of paclitaxel for advanced gastric cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel (taxol). [2019]

9. England pubmed.ncbi.nlm.nih.gov

Phase II study of paclitaxel and carboplatin in advanced gastric cancer previously treated with 5-fluorouracil and platinum. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-induced apoptosis in human gastric carcinoma cell lines. [2022]