Trial Outcomes & Findings for Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer (NCT NCT01003938)

Last Updated: 2016-06-30

Results Overview

Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by \>50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2016-06-30

Participant Flow

From Oct 2009 to May 2011, 6 patients were enrolled to this trial from New York University Medical Center and its affiliated hospitals.

Participant milestones

Participant milestones
Measure	Topotecan and Erlotinib On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topotecan and Erlotinib n=6 Participants On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Prior regimens 4 regimens	1 participants n=5 Participants
Prior regimens 5 regimens	3 participants n=5 Participants
Prior regimens 7 regimens	1 participants n=5 Participants
Prior regimens 8 regimens	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Topotecan and Erlotinib n=6 Participants On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib	1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.

Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.

Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met. SD: CA125 decreases \<50% or increases \<100%. Disease progression: CA125 doubles the value of baseline, or more, over time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.

Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Population: The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.

estimated total time from the start of the trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: the whole treatment phase and 30 days post-treatment

Number of participants (patients) who experienced AEs. Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan.

Outcome measures

Outcome measures
Measure	Topotecan and Erlotinib n=6 Participants On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
Toxicity Profile Dry skin (grade 1)	2 participants
Toxicity Profile Dry skin (grade 3)	1 participants
Toxicity Profile Dry eye (grade 1)	1 participants
Toxicity Profile Acne (grade 1)	2 participants
Toxicity Profile Erythema (grade 1)	1 participants
Toxicity Profile Rash/ desquamation (grade 1)	1 participants
Toxicity Profile Rash/ desquamation (grade 2)	1 participants
Toxicity Profile Pruritis (grade 1)	1 participants
Toxicity Profile Diarrhea (grade 1)	2 participants
Toxicity Profile Diarrhea (grade 2)	1 participants
Toxicity Profile Dehydration (grade 3)	1 participants
Toxicity Profile Anemia (grade 2)	2 participants
Toxicity Profile Anemia (grade 3)	2 participants
Toxicity Profile Leukopenia (grade 2)	3 participants
Toxicity Profile Leukopenia (grade 3)	1 participants
Toxicity Profile Nausea (grade 1)	4 participants
Toxicity Profile Nausea (grade 2)	1 participants
Toxicity Profile Nausea (grade 3)	1 participants
Toxicity Profile Vomiting (grade 1)	3 participants
Toxicity Profile Vomiting (grade 2)	1 participants
Toxicity Profile Vomiting (grade 3)	1 participants
Toxicity Profile Platelets (grade 1)	2 participants
Toxicity Profile Platelets (grade 2)	1 participants
Toxicity Profile Platelets (grade 3)	1 participants
Toxicity Profile Fatigue (grade 1)	2 participants
Toxicity Profile Fatigue (grade 2)	1 participants
Toxicity Profile Fatigue (grade 3)	1 participants

Adverse Events

Topotecan and Erlotinib

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Topotecan and Erlotinib n=6 participants at risk On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
Gastrointestinal disorders Dehydration	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.

Other adverse events

Other adverse events
Measure	Topotecan and Erlotinib n=6 participants at risk On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
Gastrointestinal disorders Anorexia	50.0% 3/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Ascites (non-malignant)	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Constipation	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
General disorders "Constitutional Symptoms-Other"	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Skin and subcutaneous tissue disorders "Dermatology/Skin-Other"	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Diarrhea patients without colostomy	50.0% 3/6 All adverse events are reported regardless of relationship to the therapy.
Eye disorders Dry eye	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Dyspepsia/heartburn	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
Renal and urinary disorders Dysuria (painful urination)	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Vascular disorders Edema	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
General disorders "Fatigue (lethargy, malaise, asthenia)"	66.7% 4/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Flatulence	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Blood and lymphatic system disorders Hemoglobin	83.3% 5/6 All adverse events are reported regardless of relationship to the therapy.
Respiratory, thoracic and mediastinal disorders "Hemorrhage-Other (Specify, nosebleeds)"	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Metabolism and nutrition disorders Hypokalemia	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Investigations Leukocytes (total WBC)	66.7% 4/6 All adverse events are reported regardless of relationship to the therapy.
Investigations Lymphopenia	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
Musculoskeletal and connective tissue disorders "Musculoskeletal-Other"	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Nausea	100.0% 6/6 All adverse events are reported regardless of relationship to the therapy.
Investigations Neutrophils/granulocytes (ANC/AGC)	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
General disorders "Pain-Other"	33.3% 2/6 All adverse events are reported regardless of relationship to the therapy.
Investigations Platelets	66.7% 4/6 All adverse events are reported regardless of relationship to the therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Skin and subcutaneous tissue disorders Rash/desquamation	50.0% 3/6 All adverse events are reported regardless of relationship to the therapy.
Renal and urinary disorders "Renal/Genitourinary-Other (Specify, urinary frequency)"	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.
Gastrointestinal disorders Vomiting	83.3% 5/6 All adverse events are reported regardless of relationship to the therapy.
Investigations Weight loss	16.7% 1/6 All adverse events are reported regardless of relationship to the therapy.

Additional Information

Franco Muggia, MD

NYU Cancer Institute

Phone: 212-263-6485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place