Chemotherapy for Stomach Cancer

(TOGAR Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Tannaz Armaghany

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Baylor College of Medicine

Disqualifiers: Metastatic disease, Prior chemotherapy, Pregnancy, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).

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 combination including Docetaxel, Fluorouracil, and Oxaliplatin for stomach cancer?

Research shows that the combination of Docetaxel, Fluorouracil, and Oxaliplatin is effective in treating advanced gastric cancer, with studies demonstrating improved outcomes like longer time before the cancer worsens and better survival rates compared to some other treatments. ^{1 2 3 4 5}

Is chemotherapy for stomach cancer using drugs like Docetaxel and 5-Fluorouracil safe?

Research shows that chemotherapy using drugs like Docetaxel and 5-Fluorouracil for stomach cancer has been studied for safety. Common side effects include neutropenia (low white blood cell count), fatigue, mouth sores, loss of appetite, and skin rash, but these vary in severity. ^{4 6 7 8 9}

How is the drug combination of Docetaxel, Fluorouracil, and Oxaliplatin unique for treating stomach cancer?

This drug combination is unique because it incorporates Docetaxel, which has shown promising results in improving response rates and survival in advanced gastric cancer when combined with other drugs like Fluorouracil and Oxaliplatin. It offers a potentially more effective option compared to traditional regimens, although it may come with manageable side effects like neutropenia (a decrease in white blood cells). ^{1 5 10 11 12}

Research Team

Tannaz Armaghany

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

Adults with confirmed gastric or gastroesophageal junction adenocarcinoma, who are fit for chemotherapy and surgery aimed at curing the cancer. They must have good organ function, no distant metastases, and be able to follow trial procedures. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

Must provide written informed consent

I am 18 years old or older.

Must have life expectancy of greater than 3 months

Exclusion Criteria

Positive cytology for metastatic disease on diagnostic laparoscopy peritoneal fluid

My cancer has spread beyond the regional lymph nodes.

My cancer has spread to other parts of my body.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy (Arm A)

Participants receive 4 cycles of FLOT chemotherapy before surgery

16 weeks

8 visits (in-person)

Surgery (Arm A)

Surgery is performed 4 weeks after the last chemotherapy cycle

1 week

1 visit (in-person)

Perioperative Chemotherapy (Arm B)

Participants receive 2 cycles of FLOT chemotherapy before and 2 cycles after surgery

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Docetaxel (Taxane)
• Fluorouracil (Anti-metabolites)
• Oxaliplatin (Alkylating agents)

Trial Overview The study is testing two approaches using FLOT chemotherapy: one where all treatment is given before surgery (Total Neoadjuvant - FLOT-TNT) versus the standard method where it's given before and after surgery (Perioperative - FLOT-POP). The goal is to see which approach has better completion rates.

Participant Groups

Group I: Arm B: FLOT-POP ( Standard Arm) Experimental Treatment 5 Interventions

Arm B us the standard perioperative arm with 2 cycles of pre-operative FLOT ( 4 treatment sessions) and 2 cycles ( 4 treatment sessions) of post-operative FLOT. Post-surgery FLOT will start 4-6 weeks post surgery. Each cycle of chemotherapy consists of 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in arm B is 8. Every effort should be done to have surgery done in week 12 ( -1 to +2 weeks) post completion of cycle 2 on ARM B.

Group II: Arm A: FLOT-TNT ( Investigational Arm) Experimental Treatment 5 Interventions

Arm A is the investigational arm with all 4 cycles of FLOT given as total neoadjuvant chemotherapy prior to surgery. Each cycle is 28 days and consists of 2 chemotherapy sessions given every 14 days. The total number of chemotherapy sessions in Arm A is 8. Every effort will be made to have surgery in week 20 ( -1 to +2 weeks), 4 weeks post C4 on arm A.

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

🇺🇸 Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇪🇺 Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇨🇦 Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇯🇵 Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baylor College of Medicine Medical Center - McNair Campus Houston, TX

Baylor St. Luke's Medical Center Houston, TX

Ben Taub Hospital Houston, TX

Harris Health System- Smith Clinic Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1044

Patients Recruited

6,031,000+

References

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

Docetaxel in the treatment of gastric cancer. [2018] Docetaxel is part of the standard chemotherapy in breast, non-small cell lung cancer and androgen-independent metastatic prostate cancer and has recently been approved for advanced gastric cancer. It demonstrated promising single-agent efficacy in gastric cancer and was therefore investigated in different combination regimens. The combination of docetaxel with 5-fluorouracil (5-FU), capecitabine, irinotecan or cisplatin demonstrated high efficacy. The triple combination of docetaxel/cisplatin and 5-FU (DCF) was investigated in randomized Phase II trials and a randomized Phase III study (TAX325). In TAX325, DCF demonstrated superiority in terms of time to tumor progression, response rate and survival against a cisplatin/5-FU combination. Docetaxel was therefore approved for advanced gastric cancer by the US FDA and the European Agency for the Evaluation of Medicinal Products and will evolve as an integral part of routine combination regimens against gastric cancer. This review will discuss and interpret the different Phase II and III trials of docetaxel in gastric cancer.

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

Third-line docetaxel chemotherapy for recurrent and metastatic gastric cancer. [2022] To determine the efficacy and toxicity of docetaxel as a third-line therapy for patients with relapsed gastric cancer who have undergone modified oxaliplatin-fluorouracil (m-FOLFOX)-4 and modified irinotecan-fluorouracil (m-FOLFIRI) regimens.

3. Greece pubmed.ncbi.nlm.nih.gov

Feasibility study of triplet combination chemotherapy of paclitaxel, cisplatin and S-1 for advanced gastric cancer. [2015] Docetaxel combined with cisplatin and 5-fluorouracil (5-FU) is active in advanced gastric cancer, but not generally accepted because of its substantial toxicities. We conducted a feasibility study of a triplet combination using paclitaxel, cisplatin and S-1 for advanced gastric cancer.

4. Japan pubmed.ncbi.nlm.nih.gov

Combination docetaxel (Taxotere), fluorouracil, and leucovorin (TFL), as first-line chemotherapy in advanced gastric cancer: a Hellenic Cooperative Oncology Group phase II study. [2022] We assessed the efficacy and safety profile of a docetaxel (Taxotere; Sanofi-Aventis, France), fluorouracil (FU), and leucovorin (LV) combination (TFL), as first-line chemotherapy in patients with advanced gastric cancer.

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

Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. [2022] The combination of docetaxel (Taxotere), cisplatin, and fluorouracil improved efficacy in gastric cancer, but was associated with substantial toxicity. This study was designed to incorporate docetaxel into a tolerable biweekly (once every 2 weeks) oxaliplatin-based chemotherapy regimen.

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

Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. [2022] To evaluate the efficacy and toxicity of docetaxel in combination with a novel oral 5-fluorouracil analogue S-1 for patients with advanced or recurrent gastric cancer.

7. Japan pubmed.ncbi.nlm.nih.gov

A phase II study of doxifluridine and docetaxel combination chemotherapy for advanced or recurrent gastric cancer. [2021] The aim of this study was to establish the efficacy and safety of doxifluridine and docetaxel for patients with advanced or recurrent gastric cancer.

8. Japan pubmed.ncbi.nlm.nih.gov

[Bi-weekly docetaxel and doxifluridine combination therapy in pretreated patients with unresectable and/or advanced gastric cancer]. [2018] We report an investigation of the therapeutic efficacy and safety of combination chemotherapy with docetaxel (DOC) and doxifluridine (5'-DFUR) administered as second-line or third-line chemotherapy in 23 cases of unresectable and/or advanced gastric cancer. Treatment consisted of intravenous DOC (40mg/m/2) on day 1 and 15, and oral 5'-DFUR (600mg/body) on days 1 to 28 every 4 weeks. The response rate for its antitumor efficacy was 17.4 %, with partial response in 4 cases, no change in 6 cases, progressive disease in 12 cases, and one case not evaluable. By site, the response rate was 11. 8% for primary tumors (2/17), 33.3% for lymph nodes (3/9) , and 26.9% for liver metastasis (1/7). Median time to treatment failure was 2.6 months, median overall survival was 4.6 months. The one-year survival rate was 26.1 %, and the two-year survival rate was 13.0%. The most common grade 3 to 4 toxicities were neutropenia( 4.3%), fatigue (8.7%), stomatitis (8.7%), anorexia(4.3% ), and rash (4.3%). Our data suggest that the combination of docetaxel and 5'-DFUR has a promising therapeutic index in patients with unresectable advanced gastric cancer as second-line or third-line chemotherapy.

9. China pubmed.ncbi.nlm.nih.gov

[Weekly dosage of docetaxel combined with cisplatin and 5-fluorouracil in the treatment of advanced gastric cancer]. [2018] To observe the effects and toxicity of docetaxel given once weekly combined with cisplatin and 5-fluororacil in the treatment of advanced gastric cancer (AGC).

10. Japan pubmed.ncbi.nlm.nih.gov

[A case of multiple skin metastases from gastric cancer successfully treated with docetaxel combined with doxifluridine]. [2018] The results of treatment of gastric cancer with docetaxel have scarcely been reported. Combination chemotherapy of docetaxel and doxifluridine was administered to five patients with recurrent or unresectable gastric cancer in the authors' department, and the overall response rate was 40%. Among them, we report here a case of multiple skin metastases successfully treated with this chemotherapy. A 71-year-old man had already undergone total gastrectomy with splenectomy about one year previously because of advanced gastric cancer: type 3, tub2, se, n1, INF gamma, ly3(+), v1(+), stage IIIa. He was treated with adjuvant chemotherapy of low-dose FP (CDDP/5-FU) for two weeks, and thereafter 5-FU (200 mg/day orally) was administered. Skin metastases appeared on the right upper eyelid and the left femoral region, though no recurrent findings were detected by CT, US, and the like one year after operation. The combination chemotherapy of docetaxel and doxifluridine was administered because multiple skin tumors rapidly appeared on the back and the right upper eyelid region. These tumors disappeared after 3 weeks and he has had no recurrence more than one year after chemotherapy.

11. Japan pubmed.ncbi.nlm.nih.gov

European experience of docetaxel and cisplatin in advanced gastric cancer. [2019] The combination of docetaxel with cisplatin in gastric cancer is a promising development. In a phase II study, 85-100 mg/m2 docetaxel plus 75 mg/m2 cisplatin was established as an active regimen in advanced gastric cancer (with an overall response rate of 56%) with a manageable safety profile. Up to 300 mg/m2 5-fluorouracil (5-FU) given by continuous infusion for 2 of 3 weeks can be added to this regimen without an increase in appreciable toxicity. The efficacy of docetaxel-based regimens remains to be established by a randomized phase III study. However, the results of such trials are eagerly awaited, as are data from studies of docetaxel-based combinations in the adjuvant and neoadjuvant settings.

12. England pubmed.ncbi.nlm.nih.gov

Docetaxel in advanced gastric cancer. [2019] Standard chemotherapy for advanced gastric cancer remains undefined. Two of the most popular regimens-ECF [epirubicin-cisplatin-5-fluorouracil (5-FU)] and PELF (cisplatin-epirubicin-5-FU-leucovorin)-have been shown to be active, but each has limitations. Phase II trials show that single-agent docetaxel is an active agent in advanced gastric cancer, producing overall response rates (ORRs) of 17.5-24%. Docetaxel has also been shown to lack cross-resistance with other drugs in gastric cancer, and is likely to be at least additive to cisplatin and 5-FU. Phase II results of docetaxel combinations in advanced gastric cancer are encouraging. Docetaxel-cisplatin has yielded response rates similar to those achieved by ECF and PELF. Adding 5-FU to docetaxel-cisplatin has achieved an ORR of 52 versus 45% for docetaxel-cisplatin in a randomized phase II trial. Docetaxel-based regimens demonstrate acceptable tolerability despite predictable hematotoxicity. Neutropenia, the major toxicity, is manageable by dose modification or by using prophylactic granulocyte colony stimulating factor. Several phase III trials are now ongoing, including a large-scale trial of docetaxel-cisplatin-5-FU versus cisplatin-5-FU. Results will show whether docetaxel improves overall response and survival, as suggested in the phase II setting.