Clinical trial · Interventional
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix
- 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)
This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
Conditions
Conditions (5)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Topotecan Hydrochloride | Drug | Topotecan | ALIAS |
| Vinorelbine Tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (paclitaxel, cisplatin)
- description
- Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
- interventionNames
- Drug: Cisplatin
- Drug: Paclitaxel
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm II (vinorelbine, cisplatin)
- description
- Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
- interventionNames
- Drug: Cisplatin
- Other: Quality-of-Life Assessment
- Drug: Vinorelbine Tartrate
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * Stage IVB, recurrent, or persistent disease * Not amenable to curative surgery and/or radiotherapy * At least 1 unidimensionally measurable lesion * At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan * Biopsy confirmation required if lesion is less than 30 mm * Target lesion must be outside of a previously irradiated field * No craniospinal metastases * Performance status - GOG 0-1 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times normal * Alkaline phosphatase no greater than 3 times normal * AST no greater than 3 times normal * Creatinine ≤ 1.2 mg/dL * Creatinine \> 1.2 mg/dL but \< 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min * No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage * Not pregnant or nursing * Fertile patients must use effective contraception * No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer * No prior malignancy whose treatment contraindicates the current study therapy * No concurrent clinically significant infection * No concurrent cytokines * At least 6 weeks since prior chemoradiotherapy and recovered * No prior chemotherapy (except when concurrently administered with radiotherapy) * At least 3 weeks since prior radiotherapy and recovered * Recovered from prior surgery
References
Publications (0)
Data not yet available