Gemcitabine + Docetaxel + Radiation for Soft Tissue Sarcoma

Overseen By Ashley Fansler, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Wake Forest University Health Sciences

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

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation.

Will I have to stop taking my current medications?

The trial requires that you stop taking any concurrent hormonal therapy, biologic, or other chemotherapy, except for women on hormonal contraceptives. If you are taking an investigational agent, you will also need to stop.

What data supports the effectiveness of the drug combination Gemcitabine and Docetaxel for treating soft tissue sarcoma?

Research shows that the combination of Gemcitabine and Docetaxel is effective for patients with metastatic soft tissue sarcoma, particularly in types like leiomyosarcoma and undifferentiated high-grade pleomorphic sarcoma. This combination is considered a useful option, although its effectiveness compared to other treatments like doxorubicin is still being evaluated. ^{1 2 3 4 5}

Is the combination of Gemcitabine and Docetaxel safe for treating soft tissue sarcoma?

The combination of Gemcitabine and Docetaxel has been studied for safety in patients with soft tissue sarcoma, and while it shows expected side effects for chemotherapy, treatment was not stopped due to these side effects. ^{1 3 4 6 7}

How is the drug combination of Gemcitabine and Docetaxel unique for treating soft tissue sarcoma?

The combination of Gemcitabine and Docetaxel is unique for treating soft tissue sarcoma because it offers a potential option when tumors become resistant to standard drugs like doxorubicine and ifosfamide. This combination has shown promising anti-tumor activity, especially in leiomyosarcomas, and is generally well tolerated, although more research is needed to confirm its benefits. ^{1 3 4 5 8}

Research Team

Shailaja Raj, MRCP

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Adults over 18 with Grade II or III soft tissue sarcoma that can be surgically removed and are eligible for pre-op radiation. They must have an ECOG performance status of 2 or less, agree to use contraception, and not be pregnant. Excluded are those on other cancer treatments, prior unplanned surgery on the limb, needing amputation, or with specific sarcoma subtypes.

Inclusion Criteria

I am 18 years old or older.

I agree to use effective birth control or abstain from sex during the study.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

My sarcoma type has standard chemotherapy treatments available.

I need an amputation for my condition.

I am not on any cancer treatments except if I'm using hormonal contraceptives.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy Plus Radiation Therapy

Participants receive up to 6 cycles of chemotherapy with a 3+3 dose escalating plan along with radiation for up to 6 weeks

6 weeks

Weekly chemotherapy and daily radiation visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Post-surgery monitoring

Long-term Follow-up

Long term follow-up will occur every 3-4 months for 24 months in person or video consultation

24 months

Treatment Details

Interventions

• Docetaxel
• Gemcitabine
• Radiation

Trial Overview The trial is testing the safety and effectiveness of combining gemcitabine and docetaxel drugs with radiation therapy before surgical removal of the tumor in adults with soft tissue sarcoma of the limbs.

Participant Groups

Group I: Neoadjuvant Chemotherapy Plus Radiation Therapy Experimental Treatment 5 Interventions

Up to 6 cycles (once a week) of chemotherapy with a 3+3 dose escalating plan (from 100 mg to 300 mg for Gemcitabine; 10 mg to 25 mg for Docetaxel) along with radiation (five days a week) for up to 6 weeks.

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The combination of gemcitabine and docetaxel has shown effectiveness in treating metastatic sarcomas, particularly in leiomyosarcoma and undifferentiated high-grade pleomorphic sarcoma, expanding treatment options for oncologists.

There is evidence suggesting that the combination may work synergistically, especially since docetaxel alone has a low response rate, indicating that using both drugs together could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and docetaxel in metastatic sarcoma: past, present, and future. Maki, RG.[2022]

Gemcitabine-based regimens, particularly gemcitabine alone and gemcitabine-docetaxel, show activity in treating pretreated uterine and non-uterine leiomyosarcoma, but the overall evidence for gemcitabine's effectiveness in sarcomas is limited due to conflicting results from non-randomized trials.

The GeDDIS phase III trial suggests that gemcitabine-docetaxel may be less effective and more toxic than doxorubicin in treating chemo-naïve metastatic soft tissue sarcoma, highlighting the need for further controlled studies to better assess its role in sarcoma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine-based chemotherapy in sarcomas: A systematic review of published trials. Ducoulombier, A., Cousin, S., Kotecki, N., et al.[2022]

In a study of 10 pediatric patients with relapsed or refractory sarcomas, the combination of gemcitabine and docetaxel showed significant antitumor activity, with 50% of patients achieving a complete or partial response.

The treatment was well-tolerated, with only mild toxicities reported, and allowed for a median duration of response of 10 months, indicating a good quality of life for the patients during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel. Mora, J., Cruz, CO., Parareda, A., et al.[2022]

In a review of 21 patients with synovial sarcoma treated with gemcitabine/docetaxel chemotherapy, the treatment showed a low response rate of only 5% and a median progression-free survival of just 2 months, indicating limited efficacy.

Despite the expected toxicities associated with this chemotherapy combination, treatment was tolerated without discontinuation due to toxicity, but the authors recommend that this regimen should not be used outside of clinical trials for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poor treatment outcomes with palliative gemcitabine and docetaxel chemotherapy in advanced and metastatic synovial sarcoma. Pender, A., Davis, EJ., Chauhan, D., et al.[2022]

References

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

Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Gemcitabine and docetaxel in metastatic sarcoma: past, present, and future. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Phase II study of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma. [2022]

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

Efficacy and safety of gemcitabine plus docetaxel in Japanese patients with unresectable or recurrent bone and soft tissue sarcoma: Results from a single-institutional analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Gemcitabine-based chemotherapy in sarcomas: A systematic review of published trials. [2022]

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

Treatment of relapsed/refractory pediatric sarcomas with gemcitabine and docetaxel. [2022]

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

Poor treatment outcomes with palliative gemcitabine and docetaxel chemotherapy in advanced and metastatic synovial sarcoma. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Docetaxel and gemcitabine combination in soft-tissue sarcomas treatment]. [2022]