Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer
MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous; Recurrence
Intervention: Paclitaxel; Oxaliplatin
Intervention description: Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in
      treating patients who have locally recurrent or metastatic cervical cancer. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Combining more than one drug may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed squamous cell,
             adenosquamous cell or adenocarcinoma of the uterine cervix

          -  Lesions must be metastatic to organs or lymph nodes outside the pelvis or must be
             locally recurrent in the pelvis after definitive therapy (surgery or radiation
             therapy) with at least 50% increase in size on sequential imaging studies

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT scan

          -  Patients may have received chemotherapy in conjunction with radiation therapy for
             primary, definitive therapy; patients may not have received treatment with cytotoxic
             agents for advanced or recurrent disease

          -  Patients who have had chemotherapy, radiation therapy or surgery must allow four weeks
             for recovery of bone marrow or recovery from surgery/radiation

          -  Life expectancy of greater than 2 months

          -  ECOG performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits

          -  The effects of oxaliplatin on the developing human fetus at the recommended
             therapeutic dose are unknown; for this reason, women of child-bearing potential and
             men must agree to use adequate contraception (hormonal or barrier method of birth
             control; abstinence) prior to study entry and for the duration of study participation;
             should a woman become pregnant or suspect she is pregnant while participating in this
             study, she should inform her treating physician immediately

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to oxaliplatin, cisplatin or carboplatin or paclitaxel or docetaxel

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because oxaliplatin is a platinating agent
             with the potential for teratogenic or abortifacient effects; because there is an
             unknown but potential risk for adverse events in nursing infants secondary to
             treatment of the mother with oxaliplatin and paclitaxel, breastfeeding should be
             discontinued if the mother is treated with oxaliplatin

          -  Because patients with immune deficiency are at increased risk of lethal infections
             when treated with marrow-suppressive therapy, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with oxaliplatin or other agents administered during the
             study; appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated