Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers

NCT03345784 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-20

Study results available
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Summary

This phase I trial studies the side effects and best dose of adavosertib when given together with external beam radiation therapy and cisplatin in treating patients with cervical, vaginal, or uterine cancer. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. External beam radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving adavosertib, external beam radiation therapy, and cisplatin may work better in treating patients with cervical, vaginal, or uterine cancer.

Conditions

  • Cervical Carcinoma
  • Endometrioid Adenocarcinoma
  • Malignant Female Reproductive System Neoplasm
  • Recurrent Cervical Carcinoma
  • Stage I Uterine Corpus Cancer AJCC v7
  • Stage I Vaginal Cancer AJCC v6 and v7
  • Stage IA Uterine Corpus Cancer AJCC v7
  • Stage IB Cervical Cancer AJCC v6 and v7
  • Stage IB Uterine Corpus Cancer AJCC v7
  • Stage IB2 Cervical Cancer AJCC v6 and v7
  • Stage II Cervical Cancer AJCC v7
  • Stage II Uterine Corpus Cancer AJCC v7
  • Stage II Vaginal Cancer AJCC v6 and v7
  • Stage IIA Cervical Cancer AJCC v7
  • Stage IIB Cervical Cancer AJCC v6 and v7
  • Stage III Cervical Cancer AJCC v6 and v7
  • Stage III Uterine Corpus Cancer AJCC v7
  • Stage III Vaginal Cancer AJCC v6 and v7
  • Stage IIIA Cervical Cancer AJCC v6 and v7
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Cervical Cancer AJCC v6 and v7
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage IIIC Uterine Corpus Cancer AJCC v7
  • Vaginal Carcinoma

Interventions

DRUG

Adavosertib

Given PO

DRUG

Cisplatin

Given IV

RADIATION

External Beam Radiation Therapy

Undergo external beam radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Stephanie Lheureux · University Health Network Princess Margaret Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2022-05-10
Completion
2022-05-10
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345784 on ClinicalTrials.gov