Paclitaxel for Ovary Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Ovary Cancer+11 More
Paclitaxel - Drug
Eligibility
18+
Female
Eligible conditions
Ovary Cancer

Study Summary

This study is evaluating whether a combination of drugs may be more effective than single drugs for treating recurrent endometrial cancer.

See full description

Eligible Conditions

  • Ovary Cancer
  • Ovarian Neoplasms
  • Fallopian Tube Cancer
  • Carcinoma, Ovarian Epithelial
  • Endometrial Neoplasms
  • Carcinoma
  • Fallopian Tube Neoplasms
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Endometrial Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Ovarian Carcinoma
  • Platinum-Resistant Ovarian Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Paclitaxel will improve 1 primary outcome and 2 secondary outcomes in patients with Ovary Cancer. Measurement will happen over the course of through study completion, an average of 1 year.

Year 1
Objective tumor response
Progression free survival
Safety and Toxicity

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (paclitaxel, lenvatinib, pembrolizumab)

This trial requires 38 total participants across 2 different treatment groups

This trial involves 2 different treatments. Paclitaxel is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (paclitaxel, lenvatinib, pembrolizumab)Patients receive paclitaxel IV over 1 hour on days -15 and -8 and lenvatinib PO QD on days -15 to 0. Beginning cycle 1 day 1, patients receive lenvatinib PO QD, pembrolizumab IV over 30 minutes on day 1, and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles with pembrolizumab repeats every 3 weeks for up to 2 years, and cycles with paclitaxel and lenvatinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Paclitaxel
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Ovary Cancer or one of the other 11 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Prior targeted therapy targeting angiogenesis is allowed as long as treatment was not discontinued due to side effects/toxicity
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Not a woman of childbearing potential (WOCBP) as defined OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months (corresponding to time needed to eliminate any study treatment[s] MK and or any active comparator/combination) plus 30 days (a menstruation cycle) after the last dose of study treatment
Patients must have received prior treatment with a platinum containing regimen and may have received 1-3 prior regimens. Hormonal therapy and maintenance therapy (with bevacizumab or PARP inhibitor) does not count towards the number of prior treatments
Participants who are at least 18 years of age on the day of signing informed consent will be enrolled in this study
Women with histologically confirmed endometrial cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (all histological subtypes)
Patients with and without mismatch repair deficiency are allowed
Prior PD-1/PD-L1 inhibitors are allowed as long as this was not the most recent regimen and treatment was not discontinued due to side effects/toxicity. Prior weekly paclitaxel is allowed as long as this was not the most recent regimen and treatment was not discontinued due to side effects/toxicity
Patients with ovarian, fallopian tube or primary peritoneal cancer must be platinum resistant (progression < 6 months after completion of a platinum containing regimen) or not a candidate for further platinum treatment
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

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 causes ovary cancer?

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At least 10% of cases of ovarian cancer may be attributed to hereditary causes. This article discusses genetic syndromes that are associated with an increased risk of ovarian cancer, including hereditary nondisjunction and Turner syndrome, and includes an update on other genetic syndromes listed in the ovarian cancer genetics section under "other risk factors" above.

Unverified Answer

What are common treatments for ovary cancer?

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Ovary cancer patients had few treatments, but there was a low rate of patient dropout because of side effects from treatments. More information on available side effects and treatment-related symptoms from patients, doctors, and caregivers should be presented.

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Can ovary cancer be cured?

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Most women will respond well to surgery; some will be cured by the surgery. In the long term, a sizeable proportion will experience relapse. Future studies assessing the timing of surgical intervention, duration of surgery and chemotherapy are required to evaluate cure rates.

Unverified Answer

What is ovary cancer?

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Ovary cancers are rare and are more common in women of older age. Ovary cancers make up approximately 10 per cent of all ovarian malignancies. The average age at diagnosis is 55. The most common subtype of ovarian cancer is serous ovarian cancer, which accounts for more than 90 per cent of ovarian cancers. Most women who present with an ovarian cancer have stage two disease. The 5-year survival rate with stage two cancer is 63 per cent. The overall stage is the most important indicator of prognosis. The 5-year survival rate is 68 per cent for stage one and 59 per cent for stage two tumors.

Unverified Answer

What are the signs of ovary cancer?

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The only symptom of ovarian cancer that can be reliably identified is painless, unilateral lump in the ovary or fallopian tube. The diagnosis of ovarian cancer by palpation alone is extremely unreliable because the testicles often present with a hard mass. However, this test should be repeated prior to removing the ovary, since this may cause the lump to disappear or become softer and more cystic. Painless metastases to other organs should also be considered as a cause of ovarian cancer. Sixty percent to seventy-five percent of patients with ovarian cancer will have a family member with an ovarian cancer history. The ovarian cancer patient must have a complete evaluation before making any decisions regarding surgery.

Unverified Answer

How many people get ovary cancer a year in the United States?

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Ovarian cancer is the ninth leading cause of women's deaths during their lifetime. In women, the leading cause of ovarian cancer is pelvic inflammatory disease and has declined since the 1980s due to improvements in screening and treatment.

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Have there been any new discoveries for treating ovary cancer?

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Our research shows that in order to find new treatments for ovarian cancer, researchers have taken on a plethora of new drugs to test on patient samples. We can see the promise, but also are there any possible side effects from these treatments? question: Is it possible to diagnose pre-cancerous (hyperplastic) lesions in uterine endometrium? answer: The most important point for pre-cancerous lesions diagnosis in uterine endometrium is not to use invasive techniques, but rather to select appropriate sampling technique. There are many cases where pre-cancerous lesions are misdiagnosed as carcinoma in situ. Hence, it is important to exclude benign from borderline epithelia.

Unverified Answer

What are the latest developments in paclitaxel for therapeutic use?

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Paclitaxel is active in combination chemotherapy, with or without fluorouracil. However, the combination of paclitaxel and docetaxel has not been evaluated in the metastatic setting to date. Given the active role of paclitaxel in metastatic breast cancer in the nonnude mouse model, it may be of reasonable usefulness in metastatic ovarian cancer. Paclitaxel appears to be active in both the neoadjuvant setting, as well as in the metastatic setting.

Unverified Answer

How serious can ovary cancer be?

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Despite a relatively low incidence of ovarian epithelial cancers, early detection and treatment of ovarian cancer is essential. The disease may be asymptomatic, but when symptoms do occur, they are non-specific with many other conditions that are more common. The best screening test for this cancer is ultrasounds once a year with the CA125 tumour marker. The best treatment is cytoreductive surgery (removing as many cancer cells as possible) with or without paclitaxel. Most advanced carcinoma of the ovary is stage 3 and in these patients, systemic chemotherapy is warranted. On the basis of these studies, it is estimated that approximately 2500 ovary cancer cases occur in the UK and 3000 cases in the USA each year.

Unverified Answer

What are the common side effects of paclitaxel?

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The most common side effects of paclitaxel include [peripheral neuropathy](https://www.withpower.com/clinical-trials/peripheral-neuropathy), fatigue, and anorexia. Other side effects include nausea, hair loss, skin rash, muscle weakness, and constipation. There are very few side effects specifically caused by paclitaxel.

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What is the average age someone gets ovary cancer?

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The average age of diagnosis for stage I and II ovarian cancer is approximately 45 years. For stage III and IV disease, the average interval from diagnosis to death is 3.0 years. This is nearly 2 years earlier than the average interval of 1-year survival for stage I and II Disease.

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Does paclitaxel improve quality of life for those with ovary cancer?

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The majority of women who were studied responded positively to PTX, demonstrating excellent QoL. The most common adverse side effects reported were pain, bleeding, and GI irritation. In a recent study, findings suggest that PTX is well tolerated and, therefore, should be considered for further testing in this setting.

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