Clinical trial · Interventional
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
NCT00082212CI-TRIAL-00003348terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to lack of sufficient efficacy.
Summary
Brief summary (as posted)
The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
- interventionNames
- Biological: Cetuximab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Every six weeks
Secondary outcomes (1)
- measure
- Relationship between response, dose, and occurence of rash
- timeFrame
- Every six weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required. * EGFR expression must be positive as determined by an outside reference lab * Subjects must have had a treatment-free interval following platinum of \<12 mos * All subjects must have measurable disease at baseline * Subjects must have at least one recurrent lesion to be used to assess response * Recovery from effect of recent surgery, radiotherapy or chemotherapy Exclusion Criteria: * Subjects with other invasive malignancies (including peritoneal mesotheliomas) * Subjects with unstable cardiac disease or MI within 6 mos * Subjects with Acute hepatitis * Subjects with active or uncontrolled infection * A history of prior cetuximab or other therapy which targets the EGFR pathway or prior history of prior chimerized or murine monoclonal antibody therapy
References
Publications (0)
Data not yet available
No reference posted for this study.