Trial Outcomes & Findings for Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma (NCT NCT00059787)
NCT ID: NCT00059787
Last Updated: 2015-12-01
Results Overview
Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2015-12-01
Participant Flow
A total of 56 patients were enrolled between June 2003 and December 2006.
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
disease progression
|
2
|
|
Overall Study
ineligible
|
1
|
|
Overall Study
Other
|
4
|
Baseline Characteristics
Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=56 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Patients who had optimally debulking surgery
Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=28 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Pathologic Complete Response Rates
|
8 participants
|
PRIMARY outcome
Timeframe: For the duration of the study up to 7 yearsPopulation: Patients enrolled on all stratums included
Adverse event assessment
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=56 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3-4 thrombocytopenia
|
7 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3-4 infection
|
7 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3-4 fatigue
|
5 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3 diarrhea
|
4 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3-4 neutropenia
|
18 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 3-4 skin rash
|
17 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 2 skin rash
|
21 percentage of participants
|
|
The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen
Grade 2 diarrhea
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: The duration of the study for up to 7 yearsPopulation: Tumor specimens were evaluated for EGFR gene amplification in 20 patients
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=20 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
To Measure EGFR Gene Amplification in Tumor Specimens
No amplification
|
11 number of tumor specimens
|
|
To Measure EGFR Gene Amplification in Tumor Specimens
Low-level amplification
|
6 number of tumor specimens
|
|
To Measure EGFR Gene Amplification in Tumor Specimens
moderate high amplification
|
3 number of tumor specimens
|
SECONDARY outcome
Timeframe: The duration of the studyOutcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=51 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin
|
34.3 months
Interval 23.9 to 51.8
|
SECONDARY outcome
Timeframe: Twelve months of maintenanceOutcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=16 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
To Determine the Tolerability of Twelve Months of Maintenance Treatment
No recurrence
|
12 participants
|
|
To Determine the Tolerability of Twelve Months of Maintenance Treatment
Recurrence
|
4 participants
|
Adverse Events
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
Serious events: 20 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=56 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
17.9%
10/56
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
4/56
|
|
Infections and infestations
Infection
|
7.1%
4/56
|
|
Skin and subcutaneous tissue disorders
Rash: desquamation
|
16.1%
9/56
|
|
General disorders
Fatigue
|
5.4%
3/56
|
|
Hepatobiliary disorders
Alanine transaminase
|
1.8%
1/56
|
|
Hepatobiliary disorders
Aspartate transaminase
|
1.8%
1/56
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
2/56
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)
n=56 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.
paclitaxel: Given IV
carboplatin: Given IV
erlotinib hydrochloride: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
4/56
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.1%
9/56
|
|
Blood and lymphatic system disorders
Anemia
|
16.1%
9/56
|
|
Metabolism and nutrition disorders
Anorexia
|
10.7%
6/56
|
|
General disorders
Fatigue
|
23.2%
13/56
|
|
Gastrointestinal disorders
Constipation
|
17.9%
10/56
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
12/56
|
|
General disorders
Nausea
|
17.9%
10/56
|
|
Skin and subcutaneous tissue disorders
Rash: desquamation
|
30.4%
17/56
|
|
Gastrointestinal disorders
Mucositis: oral
|
10.7%
6/56
|
|
Nervous system disorders
Neuropathy
|
21.4%
12/56
|
|
General disorders
Pain: abdomen
|
8.9%
5/56
|
Additional Information
NYCC Regulatory Coordinator
Montefiore Medical Center - New York Cancer Consortium
Phone: 718-379-6862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60