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Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: April 7, 2003
Last updated: October 16, 2015
Last verified: December 2012
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.

Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Drug: Paclitaxel
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall Objective Response Rate (CR+PR) [ Time Frame: Up to 7 years ]
    95% confidence interval will be estimated via binomial proportions.

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: From first treatment day until objective or symptomatic progression or death, assessed up to 7 years ]
    Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.

  • Overall Survival [ Time Frame: From first treatment day until death, assessed up to 7 years ]
    Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.

  • Toxicities, Assessed and Graded According to CTCAE Version 3.0 [ Time Frame: Up to 7 years ]
    Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities

Enrollment: 35
Study Start Date: January 2003
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel, 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.
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Oxaliplatin
Given IV

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00057863

United States, New York
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Dennis Kuo Montefiore Medical Center - Moses Campus
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00057863     History of Changes
Other Study ID Numbers: NCI-2012-03004
NCI-2012-03004 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0902-492 ( Other Identifier: Montefiore Medical Center - Moses Campus )
5840 ( Other Identifier: CTEP )
N01CM62204 ( US NIH Grant/Contract Award Number )
P30CA013330 ( US NIH Grant/Contract Award Number )
Study First Received: April 7, 2003
Results First Received: October 16, 2015
Last Updated: October 16, 2015

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017