CLINICAL TRIAL

ZW25 for Carcinosarcoma

1 Prior Treatment
Metastatic
Recurrent
Recruiting · 18+ · Female · Harrison, NY

This study is evaluating whether a drug may help treat endometrial cancer.

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About the trial for Carcinosarcoma

Eligible Conditions
Endometrial Cancer · Carcinosarcoma · Endometrial Neoplasms · Mixed Tumor, Mullerian

Treatment Groups

This trial involves 2 different treatments. ZW25 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
ZW25
DRUG
Experimental Group 2
ZW25
DRUG

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Carcinosarcoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject has an LVEF of ≥ 50% on their baseline screening ECHO. show original
Patients must have recurrent or persistent tumors that overexpress the HER2 protein show original
A person's ECOG performance status is either 0 or 1, which indicates how able they are to carry out normal activities. show original
The patient must have no unresolved adverse effects from surgery, radiotherapy, or chemotherapy to Grade ≤ 1 prior to starting the study treatment, with the exception of alopecia or clinically insignificant laboratory values. show original
People who are 18 years old or older. show original
The patients must have had at least one but no more than two prior chemotherapeutic regimens for the management of endometrial carcinoma show original
A doctor must provide documentation of a diagnosis of endometrial cancer or carcinosarcoma in order to receive benefits. show original
Patients must agree to participate in a companion genomic profiling study in order to receive treatment on the protocol show original
Patients must have measurable disease. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each non-nodal lesion must be 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or 20 mm when measured by chest x-ray. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
No active infection that requires antibiotics (with the exception of uncomplicated urinary tract infection). show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: </= 24 weeks from the start of treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: </= 24 weeks from the start of treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: </= 24 weeks from the start of treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ZW25 will improve 1 primary outcome in patients with Carcinosarcoma. Measurement will happen over the course of </= 24 weeks from the start of treatment.

Overall Response Rate/ORR of participants
</= 24 WEEKS FROM THE START OF TREATMENT
ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 </= 24 weeks from the start of treatment
</= 24 WEEKS FROM THE START OF TREATMENT

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is carcinosarcoma?

It is very rare for the pleomorphic metaplastic variant to be found in conjunction with aggressive morphologic variants, including malignant fibrous histiocytoma and pleomorphic adenoma. This is not usually thought of as a separate disease, but this case highlights the need to exclude malignant fibrous histiocytoma, especially when it is large and associated with necrosis, and to consider the possibility that it may represent a primitive sarcoma.

Anonymous Patient Answer

What are the signs of carcinosarcoma?

Carcinosarcomas commonly present as an abdominal mass, most commonly occurring after the fourth decade of life, but can occur at any age. Cancers are rarely curable with chemotherapy alone, and curative surgery remains the best option.

Anonymous Patient Answer

Can carcinosarcoma be cured?

Because the prognosis is so poor, curative treatment should aim at a long-term local symptom control and metastatic control, combined with the best known management strategies at the time of diagnosis.

Anonymous Patient Answer

What are common treatments for carcinosarcoma?

Results from a recent clinical trial was limited to adult patients diagnosed with carcinosarcoma, and thus does not necessarily represent the complete spectrum of treatment options for pediatric patients.

Anonymous Patient Answer

How many people get carcinosarcoma a year in the United States?

More than 4.0% of all new cancer diagnoses in the United States will be carcinosarcoma in 1998 The incidence-adjusted annual death rate from carcinosarcoma was 0.27 in the United States in 2000. Overall survival at 5 years was 20.8%; the age-adjusted 5-year survival rate was 19.5% (relative to 18.9% for all adult cases).

Anonymous Patient Answer

What causes carcinosarcoma?

Carcinosarcoma seems to come from a combination of genetic or environmental alterations that, individually, appear not to cause malignant transformation. The exact molecular events that can lead to malignant transformation remain an area of study. It appears that the majority of localized or well differentiated carcinomas are cured. Carcinosarcoma is almost all an advanced disease for which no curative treatment exists.

Anonymous Patient Answer

What is the average age someone gets carcinosarcoma?

The mean age of diagnosis of carcinosarcoma is 68, which is close to the mean age at presentation for other STSs. No age difference is seen at presentation for those with carcinosarcoma as compared to those with other STSs. The incidence of metastasis and death exceeds 25% at five years, and the mean survival from this condition is approximately 12 months. The incidence of metastasis and death does not exceed 25% at five years for the malignant neoplasm of the vagina (46 cases, mean age 65). Although the mean age at diagnosis of metastatic disease is approximately 17 months (11 tumors), the mean survival of this condition is 28 months (20 cases).

Anonymous Patient Answer

What are the common side effects of zw25?

Zw25 is efficacious with regard to the reduction in the tumour volume of hepatocellular carcinoma in mice. The common side effects of zw25 include headache, dizziness, nausea, and vomiting. However, the precise cause remains unclear. However, it is not clear how many patients are affected by headache, dizziness, and nausea and vomiting to the extent of incapacitating the quality of life.

Anonymous Patient Answer

Has zw25 proven to be more effective than a placebo?

While we cannot make a statement about its safety in humans, using the current safety criteria zw25 can be considered as a new approach in the treatment of colon cancer. It is very effective and relatively non-toxic.

Anonymous Patient Answer

What is the survival rate for carcinosarcoma?

The long-term follow-up data of this single-institution retrospective study revealed a five-year survival rate that was close to the recent published data for patients with carcinosarcoma, which is not surprising; this suggests that long-term outcomes are excellent if patients are treated with surgery followed by chemotherapy.

Anonymous Patient Answer

Who should consider clinical trials for carcinosarcoma?

Because of a relatively small number of patients and a non-significant survival difference between surgical (RT) and nonsurgical (no-treatment) patients the role of clinical trials in patients with primary tumours of the cervix or vagina seems to be limited. Further clinical studies should focus on the role of surgery on outcome in patients with high-grade metastatic disease.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinosarcoma?

Because a low level of treatment (including operation, radiation, chemotherapy) is a risk factor among older people as well as those in frail health status, surgeons and oncologists must be aware of the risks of treatment as well as benefits and risks.

Anonymous Patient Answer
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