Modified Capecitabine + Oxaliplatin for Gastrointestinal Cancers

Recruiting at 1 trial location

Overseen By Randall F Holcombe, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Vermont Medical Center

Must be taking: Capecitabine, Oxaliplatin

Must not be taking: Irinotecan

Disqualifiers: Hematologic, Liver, Renal, 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: 16 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.

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 allows the use of certain other anti-cancer drugs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination of capecitabine and oxaliplatin for gastrointestinal cancers?

Research shows that the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin), known as XELOX, is effective for treating advanced colorectal cancer, with a 55% response rate and a median survival of over 16 months. This suggests potential effectiveness for other gastrointestinal cancers as well. ^{1 2 3 4 5}

Is the combination of capecitabine and oxaliplatin safe for treating gastrointestinal cancers?

The combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin), known as XELOX, has been shown to be generally safe in treating colorectal cancer, with relatively infrequent severe side effects like hand-foot syndrome and neutropenia (low white blood cell count). Safety data from trials in colorectal and gastric cancers suggest that XELOX is well-tolerated, with manageable side effects. ^{1 3 4 6 7}

How is the drug combination of capecitabine and oxaliplatin unique for gastrointestinal cancers?

The combination of capecitabine (an oral medication) and oxaliplatin (given by infusion) offers a convenient and effective treatment option for gastrointestinal cancers, reducing the need for frequent hospital visits compared to traditional regimens. This approach has shown similar effectiveness to other standard treatments but with the added benefit of being simpler and requiring less time in the hospital. ^{1 3 4 8 9}

Eligibility Criteria

This trial is for patients with gastrointestinal (GI) cancers who are set to receive non-curative treatment with CAPOX or FOLFOX for over 3 months. They don't need measurable disease but must have proper kidney, blood, and liver function. Patients already on certain other cancer treatments can join, but not those on additional cytotoxic chemotherapy.

Inclusion Criteria

My treatment plan includes CAPOX or FOLFOX for more than 3 months, not aimed at curing.

I have a gastrointestinal cancer.

Exclusion Criteria

My kidney function is within the required range for chemotherapy.

My blood tests show enough neutrophils and platelets for chemotherapy.

My liver tests are within the required range for chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxaliplatin IV every 2 weeks and capecitabine orally for 7 days followed by 7 days off, with cycles repeating every 14 days

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Capecitabine
• Oxaliplatin

Trial Overview The study tests a modified schedule of capecitabine and oxaliplatin (mCAPOX) to see if it causes less toxicity than the standard regimens. It's a single-arm study focusing on how tolerable this new schedule is and what toxic effects it might have.

Participant Groups

Group I: Modified administration schedule of capecitabine with oxaliplatin Experimental Treatment 2 Interventions

* Oxaliplatin (85mg/m2), will be administered IV every 2 weeks * Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days.

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

Approved in European Union as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in United States as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Findings from Research

The XELOX regimen, combining oxaliplatin and capecitabine, demonstrated a 41.5% overall response rate in 41 patients with advanced or recurrent gastric cancer, indicating its efficacy in this challenging condition.

The treatment was associated with manageable toxicity, with only a few patients experiencing severe side effects, such as grade 3-4 neural toxicity and hematological issues, suggesting it is a viable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. Min, N., He, BF., Zhang, LS., et al.[2020]

In a phase-III trial involving 306 patients with metastatic colorectal cancer, XELOX (capecitabine plus oxaliplatin) was found to be non-inferior to FOLFOX-6 (5-fluorouracil/leucovorin plus oxaliplatin) in terms of efficacy, indicating it is a viable first-line treatment option.

Patients receiving XELOX reported greater convenience and satisfaction, spending fewer days on hospital visits and losing less time from work or daily activities compared to those on FOLFOX-6, while maintaining similar quality of life scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer. Conroy, T., Hebbar, M., Bennouna, J., et al.[2021]

In a study of 24 patients with advanced gastric cancer, the combination of oxaliplatin and capecitabine showed an overall response rate of 29.2%, indicating it can be an effective second-line chemotherapy option.

The treatment was generally well tolerated, with major side effects including bone marrow suppression and nausea/vomiting, and it provided a median time to tumor progression of 5 months and a median duration of remission of 8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oxaliplatin plus capecitabine as a second line chemotherapy for patients with advanced gastric cancer]. Qian, J., Qin, SK., Mei, JF., et al.[2018]

In a study of 50 patients with nonmetastatic colorectal cancer, adverse reactions were more frequent with the XELOX regimen (capecitabine combined with oxaliplatin), particularly neurotoxicity, thrombocytopenia, and neutropenia, compared to capecitabine monotherapy.

The type of capecitabine formulation (innovative vs. generic) did not significantly affect the safety profile; instead, the chemotherapy scheme used was the main factor influencing the occurrence of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine safety profile, innovative and generic adjuvant formulation of nonmetastatic colorectal cancer. Sánchez-Gundín, J., Torres-Suárez, AI., Fernández-Carballido, AM., et al.[2020]

In a phase III trial involving 1,886 patients with stage III colon cancer, the combination of capecitabine and oxaliplatin (XELOX) demonstrated a manageable safety profile, with treatment-related adverse events occurring at similar rates to the standard treatment of fluorouracil/leucovorin (FU/LV).

Patients receiving XELOX experienced less diarrhea and alopecia but had higher rates of neurosensory toxicity and hand-foot syndrome compared to those on FU/LV, indicating that while XELOX is generally well-tolerated, it may have specific side effects that need monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. Schmoll, HJ., Cartwright, T., Tabernero, J., et al.[2022]

In a study of 1002 patients with untreated advanced esophagogastric cancer, capecitabine was found to be noninferior to fluorouracil in terms of overall survival, with a hazard ratio of 0.86, indicating it is an effective alternative.

Oxaliplatin demonstrated similar efficacy to cisplatin, with a hazard ratio of 0.92, and was associated with fewer severe side effects, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine and oxaliplatin for advanced esophagogastric cancer. Cunningham, D., Starling, N., Rao, S., et al.[2023]

References

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

Can capecitabine replace 5-FU/leucovorin in combination with oxaliplatin for the treatment of advanced colorectal cancer? [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Oxaliplatin plus capecitabine as a second line chemotherapy for patients with advanced gastric cancer]. [2018]

6. Spain pubmed.ncbi.nlm.nih.gov

Capecitabine safety profile, innovative and generic adjuvant formulation of nonmetastatic colorectal cancer. [2020]

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

Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Comparison of S-1 plus oxaliplatin (SOX) and capecitabine plus oxaliplatin (XELOX) as adjuvant chemotherapies for stage II and III gastric cancer after D2 resection: A single-center retrospective study. [2020]

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

Capecitabine and oxaliplatin for advanced esophagogastric cancer. [2023]