Health Condition 1: null- Squamous Cell Carcinoma of the Cervix
Conditions
Interventions
Intervention1: BIOMAb-EGFR (Nimotuzumab) +: 200 mg weekly IV (Total 6 Doses)
Intervention2: Cisplatin +: 40mg/m2 weekly IV
Intervention3: Standard Radiotherapy: .
Control Intervention1: Cisplatin +Sta
Sponsors
Health Care Global Enterprises Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with advanced squamous carcinoma of the uterine cervix, FIGO stage IIB-IIIB or patients with FIGO stage IB-IIA with biopsy-proven pelvic node metastases and/or tumor size >= 5 cm. 2. Patients must have measurable disease. 3. No chemotherapy exposure prior to study entry. No prior Radiotherapy. 4. Age > 18 years < 80 years at registration. 5. Life expectancy, as judged by the treating physician, of at least 6 months 6. Zubrod performance status < = 2 7. Patients must have normal organ and marrow function 8. Normal Chest X-Ray, Chest CT, or PET-CT with no distant metastatic lesion within 8 weeks prior to study entry. 9. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1 Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years. 2 Medical illness preventing the use of full-dose chemotherapy. 3 Patients who require the use of warfarin sodium > 1 mg. 4 Previous medical or psychiatric illness that would prevent informed consent or limit survival to less than six months. 5 Prior surgery to treat carcinoma of the cervix other than biopsy. 6 Patients with positive para-aortic disease 7 Previous pelvic radiation therapy including transvaginal irradiation to control bleeding. 8 Prior systemic chemotherapy. 9 Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease. 10 Pregnant, nursing or woman of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception. 11 Clinically significant cardiac disease. 12 Any other sytemic illness expected to delay/affect the treatment delivery as per the investigators? assessment. 13 Tumor outside the pelvis. 14 Serious, non-healing wound, ulcer, or current healing fracture. 15 Patients with a history of any type of fistula or gastrointestinal perforation. 16 Patients with known hypersensitivity to recombinant human antibodies. 17 Patients who are known to be HIV positive. 18 Prior therapy that specifically and directly targets the EGFR pathway
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the progression free survivalTimepoint: At the end of 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment-related SAEs and AEsTimepoint: At any time.;2. Response RateTimepoint: .;3. Overall survival (failure: death due to any cause).Timepoint: .;4. To collect tissue to perform future immunohistochemical analyses for EGFR markers to correlate with clinical outcomeTimepoint: . | — |
Countries
India
Contacts
Public ContactDr. ChennaKeshava
Co-Investigator
Outcome results
None listed