Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00811408
• Other study ID #: CDR0000626799
• Secondary ID: IGR-CSET-2007/12
• Status: Recruiting
• Phase: Phase 1
• First received: December 18, 2008
• Last updated: January 27, 2010
• Start date: April 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of cidofovir when given as a radiosensitizer in patients with stage IB-IVA cervical cancer undergoing concurrent chemoradiotherapy.

Secondary

• Evaluate the influence of treatment on the expression of mRNA codons in HPV oncoproteins E6 and E7.

• Determine the rate of local control.

OUTLINE: This is a dose-escalation study of cidofovir.

Patients receive cidofovir IV weekly for 2 weeks prior to beginning radiotherapy and then once biweekly during radiotherapy. Patients undergo external pelvic radiotherapy for 5 weeks. Beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. Some patients may also undergo a second course of external radiotherapy to the parametrium and/or lymph nodes ≤ 3 days after brachytherapy. Patients also receive concurrent carboplatin IV once weekly during external radiotherapy and brachytherapy.

Biological expression of HPV oncoproteins E6 and E7 is analyzed during treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Drug:
• carboplatin

• cidofovir

Genetic:
• protein expression analysis

Other:
• laboratory biomarker analysis

Radiation:
• brachytherapy

• radiation therapy

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of cidofovir			Yes