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Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Nelfinavir and Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir | Drug |
| ||
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 2 years |
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Inclusion Criteria:
Laboratory work must be performed within 30 days prior to start of study treatment.
ANC ≥ 1,500/μL; Platelet count ≥ 100,000/μL; Creatinine < 2.0 mg/dL; Total Bilirubin ≤ 1.5 times normal; SGOT ≤ 3 times normal.
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Fiona Simpkins, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Lilie Lin, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| C538167 | Acidemia, isovaleric |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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