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NCT Number: NCT04188847

First-line Chemotherapy for Recurrent Cervical Cancer

The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low. This single arm, open, phase II trial would recruit 37 eligible patients. A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients. If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

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Key information

Conditions

Recurrent Cervical Carcinoma Apatinib Chemotherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Persistent Advanced Cervical Carcinoma Targeted Therapy Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vascular Endothelial Growth Factor 2 Inhibitor

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Lei Li

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female of 18-75 years old
  • Eastern Cooperative Oncology Group score 0-1
  • Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
  • An interval of 3 months or more since the fulfilling of last treatment
  • At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
  • Anticipative survival period of 3 months or more
  • Lab testing within reference ranges
  • With appropriate contraception
  • Provided consents of participating the trial

Exclusion criteria

  • With a history of exposure to other antiangiogenic agents
  • With other malignancies within past 3 years
  • With vital complications
  • With uncontrolled hypertension despite of medical treatment
  • With severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis
  • With brain metastasis
  • With addiction to psychiatric medications or with mental disorders
  • With severe open trauma, fracture or major surgery with past 4 weeks
  • With disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months
  • Urine protein ≥++, or 24 hr urine protein ≥1.0 g
  • With potential allergy or intolerance to study regimens
  • Not eligible for the study judged by researchers

Treatment and study plan

Chemotherapy plus apatinib

Drug

A combination of cisplatin, paclitaxel and apatinib would be given for all patients:

  • Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5)
  • Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks
  • Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.

Other names: First line chemotherapy plus apatinib

Primary outcomes

  1. Overall response rate

    Time frame: One year

    The rates of complete and partial remission

Secondary outcomes

  1. Progression-free survival

    Time frame: One year

    The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse

  2. Overall survival

    Time frame: One year

    The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive.

  3. Disease control rate

    Time frame: One year

    The rates of complete and partial remission, and stable disease

  4. Adverse event rates

    Time frame: One years

    The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Sponsors and collaborators

Lead sponsor

Lei Li

Other

Registry information

Official study title

Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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