Trial Outcomes & Findings for Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer (NCT NCT00317772)

Last Updated: 2022-02-07

Results Overview

Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity. The DLT (dose-limiting toxicity) is defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Continual reassessment method, prior to each 28 day cycle, an average of 60 days

Results posted on

2022-02-07

Participant Flow

The study was activated on 09/02/2004 and closed to new patient entry on 01/10/2007. All recruitments were done in a medical clinic setting.

Participant milestones

Participant milestones
Measure	Phase 1 Dose Level 1 Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Overall Study STARTED	3	3	3	10
Overall Study COMPLETED	1	1	2	1
Overall Study NOT COMPLETED	2	2	1	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 Dose Level 1 Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Overall Study Adverse Event	0	0	0	2
Overall Study Disease Progression	2	2	1	7

Baseline Characteristics

Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Level 1 n=3 Participants Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 n=3 Participants Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 n=3 Participants Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase n=10 Participants Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Age, Continuous	55 years n=5 Participants	55 years n=7 Participants	68 years n=5 Participants	60 years n=4 Participants	60 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants	19 participants n=21 Participants

PRIMARY outcome

Timeframe: Continual reassessment method, prior to each 28 day cycle, an average of 60 days

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 n=3 Participants Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 n=3 Participants Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Dose Limiting Toxicity (DLT)	2 Dose Limiting Toxicities	3 Dose Limiting Toxicities	4 Dose Limiting Toxicities	—

PRIMARY outcome

Timeframe: At end of first course, prior to each new course (28 day cycle). Continual reassessment method (CRM) during each course for toxicity, an average of 60 days

Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=9 Participants Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Maximum Tolerated Dose (MTD) of Topotecan	4 mg/m^2	—	—	—

SECONDARY outcome

Timeframe: 61 weeks

Population: Two patients received only one cycle of treatment and therefore were not evaluable for response to therapy.

Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension. Complete Response (CR): disappearance of all target and non-target lesions and no evidence of new lesions. Partial Response (PR): At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions. Increasing Disease: At least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD or appearance of new lesions within 8 weeks of study entry. Progression on existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin. Death due to disease without prior objective documentation of progression. Global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 n=3 Participants Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 n=3 Participants Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase n=10 Participants Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Response Rate Complete response	0 Participants	0 Participants	0 Participants	0 Participants
Response Rate Partial response	1 Participants	0 Participants	1 Participants	0 Participants
Response Rate Stable disease	0 Participants	1 Participants	1 Participants	1 Participants
Response Rate Progressive disease	2 Participants	2 Participants	1 Participants	7 Participants
Response Rate Not evaluable	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Phase 1 Dose Level 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 Dose Level 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 Dose Level 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Expansion Phase

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Diane C Bodurka,Chief Education & Training Ofc, Education & Training

UT MD Anderson Cancer Center

Phone: (713) 745-3358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase 1 Dose Level 1 n=3 participants at risk Topotecan 2 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 2 n=3 participants at risk Topotecan 3 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Phase 1 Dose Level 3 n=3 participants at risk Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO	Expansion Phase n=10 participants at risk Topotecan 4 mg/m2 IV on Days 1, 8, and 15 plus daily Gefitinib 250 mg given PO
Blood and lymphatic system disorders Hemoglobin	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	90.0% 9/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Blood and lymphatic system disorders Neutrophils	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	60.0% 6/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Blood and lymphatic system disorders Platelets	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	40.0% 4/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Infections and infestations Febrile neutropenia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	20.0% 2/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Dehydration	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	40.0% 4/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	60.0% 6/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	40.0% 4/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	30.0% 3/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	90.0% 9/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Mucositis	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	10.0% 1/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Constipation	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	90.0% 9/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Diarrhea	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	90.0% 9/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Nausea	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	60.0% 6/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Vomiting	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	30.0% 3/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Gastrointestinal disorders Anorexia	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	30.0% 3/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders ALT increase	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	20.0% 2/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders AST increase	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	10.0% 1/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Blood bilirubin increase	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	10.0% 1/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	33.3% 1/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	20.0% 2/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Skin and subcutaneous tissue disorders Acne	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	0.00% 0/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	60.0% 6/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
General disorders Fatigue	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	90.0% 9/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Nervous system disorders Mood alterations	100.0% 3/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	20.0% 2/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years
Nervous system disorders Neuropathy	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	66.7% 2/3 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years	50.0% 5/10 • adverse events were accessed from baseline to 30 days following the last dose of study medication received, up to 2 years