Trial Outcomes & Findings for Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer (NCT NCT00057863)
NCT ID: NCT00057863
Last Updated: 2015-11-17
Results Overview
95% confidence interval will be estimated via binomial proportions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2015-11-17
Participant Flow
A total of 35 patients were enrolled in the study from April 2003 until August 2008.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 Participants
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
|
|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 7 years95% confidence interval will be estimated via binomial proportions.
Outcome measures
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 Participants
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
|
|---|---|
|
Overall Objective Response Rate (CR+PR)
Complete Response
|
2 participants
|
|
Overall Objective Response Rate (CR+PR)
Partial Respone
|
5 participants
|
|
Overall Objective Response Rate (CR+PR)
Stable disease
|
8 participants
|
SECONDARY outcome
Timeframe: From first treatment day until objective or symptomatic progression or death, assessed up to 7 yearsAssessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Outcome measures
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 Participants
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
|
|---|---|
|
Progression-free Survival
|
21 weeks
Interval 14.7 to 27.2
|
SECONDARY outcome
Timeframe: From first treatment day until death, assessed up to 7 yearsAssessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Outcome measures
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 Participants
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
|
|---|---|
|
Overall Survival
|
52 weeks
Interval 39.4 to 64.8
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: There were 135 cycles administered.
Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities
Outcome measures
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 Participants
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
|
|---|---|
|
Toxicities, Assessed and Graded According to CTCAE Version 3.0
grade 3/4 hematologic toxicities
|
20.1 percentage of grade 3/4
|
|
Toxicities, Assessed and Graded According to CTCAE Version 3.0
grade 3/4 non-hematologic toxicities
|
34.1 percentage of grade 3/4
|
Adverse Events
Treatment (Paclitaxel, Oxaliplatin)
Serious events: 32 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
8/32 • Number of events 8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
12/32 • Number of events 12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
4/32 • Number of events 4
|
|
Vascular disorders
Thrombosis
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Coagulopathy
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • Number of events 1
|
|
Reproductive system and breast disorders
Severe vaginal hemorrhage
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Bowel perforation fistula
|
9.4%
3/32 • Number of events 3
|
|
Nervous system disorders
Neuropathy
|
15.6%
5/32 • Number of events 5
|
|
General disorders
Pain
|
25.0%
8/32 • Number of events 8
|
|
General disorders
Weakness
|
15.6%
5/32 • Number of events 5
|
|
Metabolism and nutrition disorders
Electrolytes imbalance
|
43.8%
14/32 • Number of events 14
|
|
Gastrointestinal disorders
Dehydration
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity reaction
|
3.1%
1/32 • Number of events 1
|
|
Psychiatric disorders
Psychological
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infection
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Death NOS
|
6.2%
2/32 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Oxaliplatin)
n=32 participants at risk
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
|
|---|---|
|
General disorders
Fatigue
|
28.1%
9/32 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain: Muscle
|
12.5%
4/32 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
8/32 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain: back
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Edema:limb
|
9.4%
3/32 • Number of events 3
|
|
Investigations
Leukocytes
|
15.6%
5/32 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain: Bone
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fever
|
9.4%
3/32 • Number of events 3
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Pain: Abdomen
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain: Joint
|
6.2%
2/32 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2
|
|
Nervous system disorders
Ataxia
|
6.2%
2/32 • Number of events 2
|
Additional Information
Lisa Escobar-Peralta, Program Manager
Montefiore Medical Center
Phone: 718-379-6866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60