Trial Outcomes & Findings for Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin (NCT NCT00436644)
NCT ID: NCT00436644
Last Updated: 2014-04-16
Results Overview
Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter \>= 2cm with conventional techniques or \>=1cm with spiral CT * Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart. * Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions. Non-measurable disease patients: * Decrement in CA125 by \> 50% * Improvement in other evaluable disease
COMPLETED
PHASE2
18 participants
Two consecutive evaluations at least 4 weeks apart
2014-04-16
Participant Flow
Eighteen patients were enrolled in stage 1 from February 2, 2007 to May 9, 2008.
Participant milestones
| Measure |
Lapatinib + Topotecan
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Lapatinib + Topotecan
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin
Baseline characteristics by cohort
| Measure |
Lapatinib + Topotecan
n=18 Participants
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Age, Customized
|
66 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Primary Tumor Site
Ovarian
|
16 participants
n=5 Participants
|
|
Primary Tumor Site
Peritoneal
|
2 participants
n=5 Participants
|
|
Primary Tumor Status
Platinum Resistant
|
5 participants
n=5 Participants
|
|
Primary Tumor Status
Platinum Refractory
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two consecutive evaluations at least 4 weeks apartMeasurable disease patients: measureable disease is defined as at least one lesion whose longest diameter \>= 2cm with conventional techniques or \>=1cm with spiral CT * Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart. * Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions. Non-measurable disease patients: * Decrement in CA125 by \> 50% * Improvement in other evaluable disease
Outcome measures
| Measure |
Lapatinib + Topotecan
n=18 Participants
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Response Rate (Complete Response (CR) or Partial Response (PR))
|
1 participants
|
SECONDARY outcome
Timeframe: Time from registration to progression (up to 2 years)Time to progression was defined as the number of months from registration to the date of disease progression, with patients who are progression free being censored on the date of their last evaluation.
Outcome measures
| Measure |
Lapatinib + Topotecan
n=18 Participants
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Time to Progression
|
3.5 months
Interval 1.9 to 3.9
|
SECONDARY outcome
Timeframe: Every 4 weeksNumber of patients that experienced adverse events (grade 3 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Outcome measures
| Measure |
Lapatinib + Topotecan
n=18 Participants
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Adverse Event Profile
Neutropenia
|
7 participants
|
|
Adverse Event Profile
Thrombocytopenia
|
5 participants
|
|
Adverse Event Profile
Anemia
|
1 participants
|
|
Adverse Event Profile
Leukopenia
|
2 participants
|
|
Adverse Event Profile
Diarrhea
|
4 participants
|
|
Adverse Event Profile
Nausea
|
1 participants
|
|
Adverse Event Profile
Vomiting
|
1 participants
|
|
Adverse Event Profile
Dehydration
|
2 participants
|
|
Adverse Event Profile
Hyponatremia
|
1 participants
|
|
Adverse Event Profile
Rash
|
1 participants
|
|
Adverse Event Profile
Fatigue
|
1 participants
|
SECONDARY outcome
Timeframe: Time from Registration to Death or last follow-up (up to 3 years)Overall survival time was defined as the number of months from registration to the date of death or last follow-up
Outcome measures
| Measure |
Lapatinib + Topotecan
n=18 Participants
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Overall Survival
|
15.5 months
Interval 12.2 to 24.3
|
Adverse Events
Lapatinib + Topotecan
Serious adverse events
| Measure |
Lapatinib + Topotecan
n=18 participants at risk
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
16.7%
3/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Lapatinib + Topotecan
n=18 participants at risk
Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.9%
7/18 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
5/18 • Number of events 14
|
|
Gastrointestinal disorders
Nausea
|
27.8%
5/18 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 3
|
|
General disorders
Disease Progression
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
16.7%
3/18 • Number of events 4
|
|
Investigations
Leukopenia
|
27.8%
5/18 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
88.9%
16/18 • Number of events 43
|
|
Investigations
Platelet count decreased
|
72.2%
13/18 • Number of events 33
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Pain-Bladder
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
4/18 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place