Informations générales (source: ClinicalTrials.gov)
Modulating the Expression of Oncoproteins of Papillomavirus (HPV) to Increase Radiosensitivity: a Phase I Study of Antiviral Agent Cidofovir and Chemoradiotherapy Therapy in Cervical Cancers
Interventional
Phase 1
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
avril 2008
29 juin 2024
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as
cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir
together with radiation therapy and chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in
treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who
are receiving chemotherapy together with radiation therapy.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut Gustave Roussy - F-94805 - Villejuif - France | Eric Deutsch, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix
- Stage IB2 (> 4 cm), II, III, or IVA disease
- No lumbo-aortic metastasis
- Initial tumor must be HPV-positive
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC > 2,000/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Transaminases < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 1.5 times ULN
- Bilirubin < 1.5 times ULN
- Creatinine < 1.5 times ULN
- Creatinine clearance ≥ 55 mL/min
- Proteinuria < 2 g/L
- Not pregnant
- Negative pregnancy test
- No renal disease
- No concurrent active infection
- No prior or concurrent psychiatric illness
- No history of cancer except for basal cell carcinoma
- No other active infection or serious illness that would prevent the patient from
receiving study treatment
- No known psychological, familial, social, or geographic reason that would preclude
clinical monitoring
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- More than 30 days since prior experimental drugs
- Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix
- Stage IB2 (> 4 cm), II, III, or IVA disease
- No lumbo-aortic metastasis
- Initial tumor must be HPV-positive
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC > 2,000/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Transaminases < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 1.5 times ULN
- Bilirubin < 1.5 times ULN
- Creatinine < 1.5 times ULN
- Creatinine clearance ≥ 55 mL/min
- Proteinuria < 2 g/L
- Not pregnant
- Negative pregnancy test
- No renal disease
- No concurrent active infection
- No prior or concurrent psychiatric illness
- No history of cancer except for basal cell carcinoma
- No other active infection or serious illness that would prevent the patient from
receiving study treatment
- No known psychological, familial, social, or geographic reason that would preclude
clinical monitoring
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- More than 30 days since prior experimental drugs