Clinical trial · Interventional
Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer
A Phase I Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combo Chemotherapy and Radiation
- description
- Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- interventionNames
- Drug: cisplatin
- Drug: topotecan hydrochloride
- Radiation: brachytherapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose of topotecan
- timeFrame
- Week 3 After First Course of Therapy
- description
- Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed cervical carcinoma
* Deemed not curable by surgery or radiotherapy alone
* The following stages are eligible:
* Stage IIB
* Stage IIIA or IIIB
* Stage IVA
* Stage IB or IIA with ≥ 1 of the following risk factors:
* Primary tumor ≥ 6 cm
* Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
* Positive surgical margins
* Depth of invasion \> 50% and positive capillary-lymphatic space involvement
* The following histologic subtypes are eligible:
* Squamous
* Adenosquamous
* Adenocarcinoma
* No recurrent cervical cancer
* Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
* White blood cells (WBC) ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Granulocyte count ≥ 1,500/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 times institutional normal
* Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase ≤ 3 times institutional normal
* No other prior or concurrent malignancies other than skin (excluding melanoma)
* No septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction
* No anatomic abnormalities (e.g., pelvic kidney or renal transplant) requiring modification of radiation fields
* Fertile patients must use effective contraception
* Negative pregnancy test
* Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) are eligible if disease is stable for the past 6 months
* Recovered from recent surgery
Exclusion Criteria:
* Prior pelvic radiation
* Pregnant or nursing
* History of thrombus
* History of unstable angina or myocardial infarction within the past 6 monthsReferences
Publications (0)
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