oxaliplatin in treating patients with recurrent or refractory cervical cancer

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of oxaliplatin in treating patients who have recurrent or refractory cervical cancer.

objectives: i. determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. ii. determine the nature and degree of toxicity of this drug in this patient population. outline: patients receive oxaliplatin iv over 2 hours. treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 22-60 patients will be accrued for this study within 12-14 months.

Eligibility criteria:
disease characteristics: histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapeutic measures and considered incurable bidimensionally measurable disease must not be eligible for a higher priority gog protocol no known brain metastases patient characteristics: age: not specified performance status: gog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 granulocyte count at least 1,500/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 3 times uln alkaline phosphatase no greater than 3 times uln renal: creatinine normal cardiovascular: no symptomatic congestive heart failure no unstable angina pectoris no cardiac arrhythmia other: not pregnant or nursing fertile patients must use effective contraception no evidence of preexisting peripheral sensory neuropathy greater than ctc grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) no history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy no other uncontrolled concurrent illness (e.g., ongoing or active infection) no other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy prior concurrent therapy: biologic therapy: no concurrent colony stimulating factors (csfs) during first course of therapy at least 24 hours since prior csfs during subsequent courses of therapy chemotherapy: at least 3 weeks since prior chemotherapy and recovered no prior oxaliplatin no more than 1 prior chemotherapy regimen endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: at least 3 weeks since prior surgery and recovered other: at least 3 weeks since prior anticancer therapy and recovered no other concurrent investigational agents no concurrent antiretroviral therapy (haart)

Keywords: recurrent cervical cancer cervical squamous cell carcinoma