Patients with stage IB2, IIA2, IIB, III, and IVA cervical cancer, according to the FIGO classification.
Conditions
Interventions
Product Name: Mapatumumab
Product Code: TRM-1
Pharmaceutical Form: Solution for infusion
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed stage IB2, IIA2, IIB, III, and IVA cervical cancer, according to the FIGO classification (see appendix A) 2. Adequate bone marrow, renal and liver function 3. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix B) 4. Age 18 years or older 5. Life expectancy of = 12 weeks 6. Have the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complications or reduces the possibility of assessing clinical effect. 2. Cytotoxic agent, hormonal therapy, or radiation therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to day 1, cycle 1; investigational agent within 4 weeks prior to day 1, cycle 1. 3. Need for concomitant anticancer therapy (surgery, radiation therapy, chemotherapy, immunotherapy, radiofrequency ablation) or other investigational agents during the study treatment period. 4. Major surgery within 4 weeks before enrollment; minor surgery (except for insertion of vascular access device) within 2 weeks before enrollment; or not yet recovered from the effects of the surgery. 5. Systemic steroids within 1 week before enrollment except steroids used as part of an antiemetic regimen or maintenance-dose steroids for non-cancerous disease. 6. History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment. 7. Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids. 8. Known human immunodeficiency virus infection. 9. Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix D) within 6 months before enrollment. 10. Pregnant female or nursing mother.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b: To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer Phase 2: To evaluate the efficacy of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer;Secondary Objective: Phase 1b: -To determine the dose of mapatumumab that can be administered safely in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer, with a maximal dose of 30 mg/kg. -To compare pre treatment molecular parameters to that during and after treatment. Phase 2: -To evaluate the safety and tolerability of the mapatumumab doses identified for further evaluation in phase 1b. -To compare pre treatment molecular parameters to those during and after treatment. ;Primary end point(s): Phase 2: Pathologic complete response rate at 8-10 weeks following the last dose of radiotherapy. | — |
Countries
Netherlands
Outcome results
None listed