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

Primary Purpose

Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center - Moses Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, oxaliplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Objective Response Rate (CR+PR)
95% confidence interval will be estimated via binomial proportions.

Secondary Outcome Measures

Progression-free Survival
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Overall Survival
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
Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities

Full Information

First Posted
April 7, 2003
Last Updated
October 16, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00057863
Brief Title
Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
Official Title
A Phase II Study of Oxaliplatin in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVES: 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. OUTLINE: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, oxaliplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, TAX
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Objective Response Rate (CR+PR)
Description
95% confidence interval will be estimated via binomial proportions.
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time Frame
From first treatment day until objective or symptomatic progression or death, assessed up to 7 years
Title
Overall Survival
Description
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time Frame
From first treatment day until death, assessed up to 7 years
Title
Toxicities, Assessed and Graded According to CTCAE Version 3.0
Description
Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Kuo
Organizational Affiliation
Montefiore Medical Center - Moses Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19931137
Citation
Kuo DY, Blank SV, Christos PJ, Kim M, Caputo TA, Pothuri B, Hershman D, Goldman N, Ivy PS, Runowicz CD, Muggia F, Goldberg GL, Einstein MH. Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer: a New York Cancer Consortium Study. Gynecol Oncol. 2010 Mar;116(3):442-6. doi: 10.1016/j.ygyno.2009.10.082. Epub 2009 Nov 20.
Results Reference
derived

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

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