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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03004 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-5840 | |||
| 0902-492 | Other Identifier | Montefiore Medical Center - Moses Campus | |
| 5840 | Other Identifier | CTEP | |
| N01CM62204 | U.S. NIH Grant/Contract | View source | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (paclitaxel, oxaliplatin) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Objective Response Rate (CR+PR) | 95% confidence interval will be estimated via binomial proportions. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae. | From first treatment day until objective or symptomatic progression or death, assessed up to 7 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Kuo | Montefiore Medical Center - Moses Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467-2490 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19931137 | Derived | 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. |
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A total of 35 patients were enrolled in the study from April 2003 until August 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Oxaliplatin | Drug | Given IV |
|
Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae. |
| From first treatment day until death, assessed up to 7 years |
| 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 | Up to 7 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Objective Response Rate (CR+PR) | 95% confidence interval will be estimated via binomial proportions. | Posted | Number | participants | Up to 7 years |
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| Secondary | Progression-free Survival | Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae. | Posted | Mean | 95% Confidence Interval | weeks | From first treatment day until objective or symptomatic progression or death, assessed up to 7 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae. | Posted | Mean | 95% Confidence Interval | weeks | From first treatment day until death, assessed up to 7 years |
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| 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 | There were 135 cycles administered. | Posted | Number | percentage of grade 3/4 | Up to 7 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Febrile neutropenia | Blood and lymphatic system disorders |
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| Anemia | Blood and lymphatic system disorders |
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| Thrombocytopenia | Blood and lymphatic system disorders |
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| Thrombosis | Vascular disorders |
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| Coagulopathy | Investigations |
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| Nausea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Colitis | Gastrointestinal disorders |
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| Severe vaginal hemorrhage | Reproductive system and breast disorders |
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| Bowel perforation fistula | Gastrointestinal disorders |
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| Neuropathy | Nervous system disorders |
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| Pain | General disorders |
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| Weakness | General disorders |
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| Electrolytes imbalance | Metabolism and nutrition disorders |
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| Dehydration | Gastrointestinal disorders |
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| Hypersensitivity reaction | Skin and subcutaneous tissue disorders |
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| Psychological | Psychiatric disorders |
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| Infection | Infections and infestations |
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| Death NOS | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
| |||
| Pain: Muscle | Musculoskeletal and connective tissue disorders |
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| Alopecia | Skin and subcutaneous tissue disorders |
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| Pain: back | Musculoskeletal and connective tissue disorders |
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| Edema:limb | General disorders |
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| Leukocytes | Investigations |
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| Pain: Bone | Musculoskeletal and connective tissue disorders |
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| Fever | General disorders |
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| Aspartate aminotransferase increased | Metabolism and nutrition disorders |
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| Alkaline phosphatase | Metabolism and nutrition disorders |
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| Pain: Abdomen | Gastrointestinal disorders |
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| Pain: Joint | Musculoskeletal and connective tissue disorders |
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| Insomnia | Psychiatric disorders |
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| Ataxia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Escobar-Peralta, Program Manager | Montefiore Medical Center | 718-379-6866 | lescobar@montefiore.org |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D056831 | Coordination Complexes |
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| Asian |
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