Using Gemcitabine for Cervical Cancer Treatment in Patients with Kidney Issues

A Phase II Clinical Trial to Evaluate the Potential of Concomitant Chemoradiotherapy With Gemcitabine in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

This study is testing if gemcitabine can be a safer and effective treatment option for women with advanced cervical cancer who also have kidney problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: National Institute of Cancerología (Government)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT03101995 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of gemcitabine as a chemoradiotherapy option for women with locally advanced cervical cancer who also have renal disease. Given the nephrotoxic effects of the standard treatment, cisplatin, this study aims to determine if gemcitabine can provide a safer alternative while still improving patient outcomes. The trial will involve administering gemcitabine alongside radiotherapy to assess its impact on overall survival and local recurrence rates. Participants will be closely monitored for side effects and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with locally advanced cervical cancer and renal impairment.

Not a fit: Patients with early-stage cervical cancer or those without renal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a safer treatment option for cervical cancer patients with compromised kidney function.

How similar studies have performed: While cisplatin is the standard treatment, the use of gemcitabine in this context is novel and has not been extensively tested in similar trials.

Eligibility criteria

Inclusion criteria.

1. Patients who give their written consent to participate in the study.
2. Women, 18-70 years of age, considering the following criteria:

   • In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT).

   ii. The patient must accept the use of any contraceptive method approved by the attending physician during the study and 12 weeks after the end of treatment.

   • Postmenopausal women must meet at least one of the following parameters for eligibility: i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age \< 60 years, with amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal parameters.
3. Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm.
4. With histologic confirmation of squamous carcinoma, adenosquamous carcinoma, adenocarcinoma or glassy cells carcinoma.
5. Without previous treatment and medically able to receive gemcitabine.
6. Disease measurable by CT and/or MRI according to RECIST (v1.1) criteria.
7. Functional status of 0-3 according to WHO criteria.
8. Renal dysfunction defined by glomerular filtration (GF) \<60 ml/min/1.73m2 calculated by the CKD-EPI formula.
9. Normal hematologic and liver function, as defined by the following parameters:

   * Hemoglobin \> 10g/L. (Transfusion prior to the treatment is allowed to reach this level of hemoglobin).
   * Leucocytes \> 4000/mm3.
   * Platelets \> 100,000/mm3.
   * Total Bilirubin ≤1.5 times the upper normal limit (UNL).
   * Transaminases \< 1.5 times the UNL.
10. Normal PA chest radiograph.

Exclusion criteria.

1. Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma.
2. Patients with diabetes and/or hypertension with retinopathy or albuminuria \>300.
3. Patients with evidence of active TB infection.
4. Patients infected with Human Immunodeficiency Virus (HIV).
5. Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage.
6. Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis.
7. Patients with uncontrolled intercurrent diseases including active infections that contraindicate QT, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, decompensated diabetes, difficult control hypertension and psychiatric illness.
8. Concomitant treatment with other experimental drugs.
9. Social, family or geographical conditions that suggest a poor adherence to the study.

Study discontinuation criteria.

1. Evidence of disease progression, if the researcher considers that the patient would benefit more with other therapy.
2. At the request of the patient.
3. By unacceptable toxicity.
4. Pregnancy.

Violation of starting criteria. Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.

Where this trial is running

Mexico City, Mexico City

• National Institute of Cancer — Mexico City, Mexico City, Mexico (Recruiting)

Study contacts

• Principal investigator: Lucely C Cetina, MD, M.Sc. — National Institute of Cancerología
• Study coordinator: Lucely C Cetina, MD, M.Sc.

Conditions Cervical Cancer; Treatment; Locally advanced cervical cancer; Renal failure; Gemcitabine