Capecitabine and Docetaxel in Advanced/Recurrent Cervical Cancer
Capecitabine and Docetaxel in Advanced/Recurrent Cervical Cancer
The purpose of the study is to evaluate the effectiveness and side effects of the drugs
 capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by
 the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment
 of breast and lung cancer. The use of capecitabine and docetaxel in this study for the
 treatment of cervical cancer is considered investigational. Eligible subjects will take the
 drug capecitabine (Xeloda) by mouth twice a day every 12 hours, for fourteen consecutive days
 followed by a 7 day rest period. Subjects will also receive the drug docetaxel (Taxotere)
 intravenously (in the vein) every three weeks.
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.