Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer

May 10, 2023 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Oral Topotecan Combined With Anlotinib in Patients With Platinum-resistant Recurrent Ovarian Cancer：

The goal of this clinical trial is to evaluate the treatment of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in Patients with platinum-resistant recurrent epithelial ovarian cancer. The main questions it aims to answer are: to assess the objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS) and safety of topotecan hydrochloride capsules combined with anlotinib hydrochloride capsules in patients with platinum-resistant recurrent epithelial ovarian cancer.The treatment of participants： Topotecan hydrochloride capsules: 2 mg, once daily, oral with dinner for 5 days, discontinued for 16 days, that is, 21 days (3 weeks) as a course of treatment, a total of 6 courses of administration.；Anlotinib hydrochloride capsules: 10mg once a day, oral before breakfast, continuous administration for 14 days, discontinuation for 7 days, that is, 21 days (3 weeks) as a course of treatment. Receiving optimal supportive care at the same time until disease progression/death/intolerable toxicity.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥ 18 years old;
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  3. The pathological type is epithelial ovarian cancer: high-grade serous, clear cell, endometrium-like; or fallopian tube cancer, primary peritoneal cancer;
  4. After surgery, the patient received ≥ 2 lines of chemotherapy,Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy);
  5. Clinical recurrence with measurable lesions (with imaging evidence);
  6. Estimated survival≥ 3 months;
  7. The main organs function well, and the examination indicators meet the following requirements: 1) Routine blood test: hemoglobin ≥ 90 g/L (no transfusion within 14 days); Neutrophil count≥ 1.5×109/L; Platelet count≥ 80×109/L; 2) Biochemical examination: Total bilirubin ≤1.5×ULN (upper limit of normal); Blood valley alanine aminotransferase (ALT) or blood valley aminotransferase (AST) ≤ 2.5×ULN; ALT or AST ≤ 5×ULN if liver metastases are present; Serum creatinine ≤ 1.5×ULN or endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
  8. Good compliance, family members agree to cooperate with survival follow-up.

Exclusion Criteria:

  1. Have other malignant tumors at the same time, except for malignant tumors that have been cured or stabilized;
  2. Pregnant or lactating women;
  3. Participated in clinical trials of other drugs within six months;
  4. Have a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
  5. Any bleeding event with a severe grade of 3 or above in CTCAE 4.0 within 4 weeks prior to screening;
  6. Patients with known central nervous system metastases or history of central nervous system metastases before screening;
  7. Patients with hypertension who cannot be well controlled by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina; Patients with a new diagnosis of angina within 3 months before screening or a myocardial infarction event within 6 months before screening; Arrhythmias require long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ II cardiac insufficiency;
  8. Long-term unhealed wounds or incompletely healed fractures;
  9. Previous organ transplantation history;
  10. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal hemorrhage;
  11. Coagulation dysfunction (prothrombin time>16s, Activated partial thromboplastin>43s, thrombin time>21s, fibrinogen<2g/L), with bleeding tendency (14 days before randomization must meet: INR within normal value without anticoagulant); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; Under the premise of the international normalized ratio (INR) of prothrombin time (INR) ≤ 1.5, the use of low-dose warfarin (1 mg orally once daily) or low-dose aspirin (not exceeding 100 mg daily) for prophylactic purposes is permitted;
  12. Screen for arteriovenous thrombotic events within one year before, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization with chemotherapy in the early stage of chemotherapy and judged to have been cured by the investigator) and pulmonary embolism;
  13. Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  14. Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  15. According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of patients or affect the completion of the study;
  16. History of surgical procedures within 28 days;
  17. History of abdominal fistula or gastrointestinal perforation within 28 days;
  18. Those who may receive other systemic anti-tumor therapy or plan to undergo ovarian cancer debulking surgery during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Topotecan Combined With Anlotinib
Drug: Oral Topotecan Combined With Anlotinib
Topotecan hydrochloride capsules: 2 mg, once daily, oral with dinner for 5 days, discontinued for 16 days, that is, 21 days (3 weeks) as a course of treatment, a total of 6 courses of administration.；Anlotinib hydrochloride capsules: 10mg once a day, oral before breakfast, continuous administration for 14 days, discontinuation for 7 days, that is, 21 days (3 weeks) as a course of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS)
Time Frame: one year
one year
disease control rate (DCR)
Time Frame: one year
one year
duration of response (DOR)
Time Frame: one year
one year
overall survival (OS)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Xipeng Wang, Dr, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

February 1, 2026

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-22-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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