Clinical trial · Interventional
Effectiveness of Chemotherapy in Metastatic or Recurrent Carcinoma Cervix
An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
NCT02492503CI-TRIAL-00018484unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Carcinoma Recurrent | — | UNRESOLVED | — |
| Metastatic Carcinoma to the Uterine Cervix | — | UNRESOLVED | — |
| Recurrent Carcinoma Cervix | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- pacli carb 3
- description
- Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly
- interventionNames
- Drug: Paclitaxel and carboplatin
- type
- ACTIVE_COMPARATOR
- label
- pacli carb 1
- description
- Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
- interventionNames
- Drug: Paclitaxel and carboplatin
Primary outcomes (1)
- measure
- Time to progression (length of time from start of chemotherapy to evidence of cancer progression.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Histologically proven case of squamous or adenocarcinoma or adenosquamous carcinoma 2.ECOG performance status 0,1 and 2 3.Adequate hematologic, renal and liver functions 4.Informed consent 5.Measurable disease by CT scan or USG abdomen or MRI \- Exclusion Criteria: 1. ECOG performance status 3 or 4 2. Impaired blood counts: those patients with an absolute neutrophil count \<1,500/μL, platelet counts \<100,000/μL, will be ineligible. 3. Impaired renal /liver functions as indicated by: Serum bilirubin \>1.5× normal, AST level more than 3× normal, Alkaline phosphatase level more than 3× institutional normal, or a Serum creatinine level more than 1.2 mg/dL. Patients with serum creatinine level of more than 1.2 mg/dL but less than 1.5 mg/dL are eligible if creatinine clearance is 70 ml/min were eligible if a creatinine clearance determination was more than 50 mL/min. 4\. H/o prior chemotherapy for metastatic disease, 5. H/O concurrent or past malignancy other than carcinoma cervix, 6. CNS metastasis, or 7. Bilateral hydronephrosis that could not be alleviated by ureteral stents or percutaneous nephrostomy. \-
References
Publications (0)
Data not yet available
No reference posted for this study.