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A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer

Phase 2
18 Years
Not Enrolling
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer

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Trial Information

A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer


I. To determine the objective response rates for the combination of paclitaxel and
oxaliplatin in patients with metastatic or locally recurrent cervical cancer.

II. To determine the toxicities and recovery from toxicities of patients with cervical
cancer receiving paclitaxel and oxaliplatin.


Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed ever 3 months.

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

Type of Study:


Study Design:

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

Outcome Measure:

Overall objective response rate (CR+PR)

Outcome Description:

95% confidence interval will be estimated via binomial proportions.

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Dennis Kuo

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Cancer
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous



Montefiore Medical Center Bronx, New York  10467-2490