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ATR Kinase Inhibitor
Adavosertib + Radiotherapy + Chemotherapy for Cancer of the Female Reproductive System
Phase 1
Waitlist Available
Led By Stephanie Lheureux
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have one of the following biopsy proven gynecological cancer and a decision to treat with radiotherapy and concurrent cisplatin chemotherapy (RT-CT)
Newly diagnosed epithelial carcinoma of the cervix, cT1B-3B, N0/1, M0/1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of a drug called adavosertib when given with external beam radiation therapy and cisplatin to treat patients with cervical, vaginal, or uterine cancer.
Who is the study for?
This trial is for patients with cervical, vaginal, or uterine cancer who have a life expectancy over 3 months and good performance status. They must not have had previous pelvic radiotherapy but should be planned to receive it along with chemotherapy. Eligible participants need adequate blood counts and organ function, can swallow capsules, agree to use birth control if of childbearing potential, and haven't received prior treatment for their current cancer.Check my eligibility
What is being tested?
The trial tests the combination of adavosertib with external beam radiation therapy and cisplatin in treating gynecological cancers. It aims to find the best dose of adavosertib that's effective yet has manageable side effects when used alongside standard treatments like radiation and cisplatin chemotherapy.See study design
What are the potential side effects?
Potential side effects include those related to adavosertib such as nausea, fatigue, blood cell count changes; from radiation therapy like skin irritation or discomfort at the treatment site; and from cisplatin including kidney issues, hearing loss, nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a gynecological cancer and will be treated with radiation and cisplatin.
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I have been newly diagnosed with cervical cancer that has not widely spread.
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I have a new diagnosis of vaginal cancer that has not widely spread.
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My cervical or uterine cancer has returned in the pelvis area after surgery but I haven't had pelvic radiotherapy.
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I am scheduled for pelvic radiotherapy with a dose of 45 Gy or more.
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I am fully active or have some restrictions but can still care for myself.
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My bilirubin levels are within the normal range or slightly elevated if I have liver metastases or Gilbert's syndrome.
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I can swallow whole capsules.
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I can receive weekly cisplatin treatments.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities
Secondary outcome measures
Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin
Progression-free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, adavosertib, cisplatin)Experimental Treatment3 Interventions
Patients undergo external beam radiation therapy on days 1-5 and receive adavosertib PO on days 1, 3, and 5 or QD on days 1-5 and cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Adavosertib
2015
Completed Phase 2
~570
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,631 Total Patients Enrolled
Stephanie LheureuxPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
5 Previous Clinical Trials
525 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not HIV-positive or on antiretroviral therapy.I have a new diagnosis of vaginal cancer that has not widely spread.My bilirubin levels are within the normal range or slightly elevated if I have liver metastases or Gilbert's syndrome.I have a gynecological cancer and will be treated with radiation and cisplatin.I have had radiation therapy to my pelvic area before.I can swallow whole capsules.Your blood clotting tests should be within the normal range.I have a specific type of uterine cancer and can't have surgery right away due to the disease's spread.Your liver enzymes (AST and ALT) should not be more than 3 times the upper limit of normal, or 5 times if you have liver metastases.I can receive weekly cisplatin treatments.I am a woman able to have children and had a negative pregnancy test within the last 28 days.My cancer has spread to nearby lymph nodes or other areas, but my team believes targeted radiation can control it.I have no other active cancers and any past cancers have been treated successfully.My heart's electrical activity is normal and I haven't had serious heart rhythm problems.I agree to use two forms of birth control or abstain from sex during and for 4 months after the study.My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.I can receive blood transfusions at any time if needed.I do not have any severe illnesses that are not under control.You are expected to live for more than 3 months.My cervical or uterine cancer has returned in the pelvis area after surgery but I haven't had pelvic radiotherapy.I am scheduled for pelvic radiotherapy with a dose of 45 Gy or more.I am fully active or have some restrictions but can still care for myself.You have a low level of white blood cells.Your white blood cell count is at least 1,500 per microliter.I have received chemotherapy or radiotherapy for my current gynecological cancer.I need radiotherapy in the area around my aorta.I am allergic to medications similar to AZD1775 or cisplatin.I haven't had bowel blockage or absorption issues in the last 3 months.I have had significant bleeding issues in the past.I am not currently on any experimental drugs or cancer treatments.I am not pregnant or breastfeeding.I have been newly diagnosed with cervical cancer that has not widely spread.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy, adavosertib, cisplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any prior experiments involving External Beam Radiation Therapy?
"At the present time, there are 763 studies involving External Beam Radiation Therapy in progress with 289 of these trials currently at Phase 3. While many clinical sites for this therapy are located in Shanghai, an aggregate of 45,799 worldwide locations offer research opportunities related to External Beam Radiation Therapy."
Answered by AI
What medical conditions commonly necessitate treatment with External Beam Radiation Therapy?
"External Beam Radiation Therapy can be an effective treatment for advanced ovarian cancer and neoplasm metastasis that is unresponsive to other therapies."
Answered by AI
Are there any openings remaining in this trial?
"According to the data found on clinicaltrials.gov, this medical study is not presently looking for participants; it was initially posted in October 2017 and last updated in November 2022. However, there are 3586 other trials that have openings for patients at present."
Answered by AI
Has the FDA validated External Beam Radiation Therapy for use?
"As this trial is still in the early stages, our team at Power gave External Beam Radiation Therapy a score of 1; given its status as a Phase 1 study, there are limited safety and efficacy data."
Answered by AI
Approximately how many participants are currently enrolled in this investigation?
"Unfortunately, this trial is no longer open for enrolment. The research was first posted on October 23rd 2017 and had its last update November 29th 2022. Other clinical trials are available; as of now there are 2823 studies currently recruiting patients with endometrioid adenocarcinoma and 763 involving External Beam Radiation Therapy that require participants."
Answered by AI
How many locations is the administration of this research occurring?
"Currently, 8 clinical trial sites are recruiting patients. These include Sacramento, Durham and Vancouver as well as 5 other places. To optimise travel needs, it is advised to select the clinic closest to you if you choose to take part in this study."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
65+
What site did they apply to?
University of Kentucky/Markey Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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