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A Phase II Trial of Capecitabine and Docetaxel in the Treatment of Advanced and Recurrent Cervical Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

A Phase II Trial of Capecitabine and Docetaxel in the Treatment of Advanced and Recurrent Cervical Cancer


Inclusion Criteria:



1. Patients must have histologically proven stage IVB, recurrent or persistent squamous
cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not
amenable to curative treatment with surgery and/or radiation therapy

2. Age greater than or equal to 18

3. All patients must have measurable disease. Measurable disease is defined as at least
one lesion that can be accurately measured in at least one dimension (longest
dimension to be recorded). Each lesion must be greater than or equal to 20 mm when
measured by conventional techniques, including palpation, plain x-ray, CT, and MRI,
or greater than or equal to 10 mm when measured by spiral CT. Biopsy confirmation is
required if the lesion measures < 30 mm or if the treating physician determines it is
clinically indicated. Patients must have at least one "target lesion" to be used to
assess response on this protocol as defined by Response Evaluation Criteria in Solid
Tumors (RECIST). This lesion should be the one that was biopsied if one was
performed. Patients with tumors within and outside a previously irradiated field
should have the lesion outside of the irradiated area preferentially designated as
the "target" lesion.

4. Patients must have adequate:

- Hematologic function: ANC greater than or equal to 1500/mm3; Platelets greater
than or equal to 100,000/mm3; Hemoglobin greater than or equal to 8.0 g/dl

- Renal function: Serum creatinine less than or equal to 1.2 mg/dl. Patients
with a serum creatinine greater than 1.2 mg/dl but less than 1.5 mg/dl must have
a 24-hour creatinine clearance determination of > 50 cc/min to be eligible.

- Hepatic function: Total Bilirubin must be within normal limits. Transaminases
(SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN)
if alkaline phosphatase is less than or equal to ULN, or alkaline phosphatase
may be up to 4 x ULN if transaminases are less than or equal to ULN

5. Patients must have a GOG Performance Status of 0 or 1.

6. Patients must have recovered from the effects of surgery, radiation therapy, or
chemoradiotherapy. At least six weeks must have elapsed from the last administration
of chemoradiotherapy, and at least three weeks must have elapsed from the last
administration of radiation therapy alone.

7. Patients must have signed an approved informed consent form.

8. Patients must be free of clinically active infection.

9. Women of childbearing potential must have a negative pregnancy test. Women of
childbearing potential must be willing to consent to using effective contraception
while on treatment until they reach menopause.

Exclusion Criteria:

1. Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents
or percutaneous drainage. Patients with a serum creatinine greater than 1.2 mg/dl
but less than 1.5 mg/dl with a 24-hour creatinine clearance determination of < 50
cc/min.

2. Patients with a serum creatinine of 1.5 mg/dl or greater.

3. Patients previously treated with chemotherapy except when used concurrently with
radiation therapy

4. Patients with a history of severe hypersensitivity reaction to docetaxel, drugs
formulated with polysorbate 80, fluoropyrimidine therapy or 5-FU.

5. Patients who are pregnant or lactating

6. Patients with craniospinal metastases or history of craniospinal metastases.

7. Patients with a concomitant malignancy other than non-melanoma skin cancer.

8. Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have
had any evidence of disease within the last 5 years or whose prior malignancy
treatment contraindicates the current protocol therapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate response rate

Outcome Description:

Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required.

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Bradley J. Monk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 03-04

NCT ID:

NCT00257348

Start Date:

March 2004

Completion Date:

July 2007

Related Keywords:

  • Cervical Cancer
  • Advanced Cervical Carcinoma
  • Recurrent Cervical Carcinoma
  • Uterine Cervical Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868