Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Recurrent Cervical Carcinoma, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer
Conditions
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.
Interventions
DRUGPaclitaxel
Given IV
DRUGOxaliplatin
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Objective Response Rate (CR+PR) | Up to 7 years | 95% confidence interval will be estimated via binomial proportions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 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 | 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 | Up to 7 years | Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities |
Countries
United States
Participant flow
Recruitment details
A total of 35 patients were enrolled in the study from April 2003 until August 2008.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Paclitaxel: Given IV
Oxaliplatin: Given IV | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment (Paclitaxel, Oxaliplatin) |
|---|---|
| Age, Continuous | 56 years |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Black | 8 participants |
| Race/Ethnicity, Customized Hispanic | 9 participants |
| Race/Ethnicity, Customized White | 12 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 32 |
| serious Total, serious adverse events | 32 / 32 |
Outcome results
Primary
Overall Objective Response Rate (CR+PR)
95% confidence interval will be estimated via binomial proportions.
Time frame: Up to 7 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Paclitaxel, Oxaliplatin) | Overall Objective Response Rate (CR+PR) | Complete Response | 2 participants |
| Treatment (Paclitaxel, Oxaliplatin) | Overall Objective Response Rate (CR+PR) | Partial Respone | 5 participants |
| Treatment (Paclitaxel, Oxaliplatin) | Overall Objective Response Rate (CR+PR) | Stable disease | 8 participants |
Secondary
Overall Survival
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment (Paclitaxel, Oxaliplatin) | Overall Survival | 52 weeks |
Secondary
Progression-free Survival
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment (Paclitaxel, Oxaliplatin) | Progression-free Survival | 21 weeks |
Secondary
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
Time frame: Up to 7 years
Population: There were 135 cycles administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Paclitaxel, Oxaliplatin) | Toxicities, Assessed and Graded According to CTCAE Version 3.0 | grade 3/4 hematologic toxicities | 20.1 percentage of grade 3/4 |
| Treatment (Paclitaxel, Oxaliplatin) | Toxicities, Assessed and Graded According to CTCAE Version 3.0 | grade 3/4 non-hematologic toxicities | 34.1 percentage of grade 3/4 |