Trial Outcomes & Findings for Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma (NCT NCT00630409)

Last Updated: 2017-03-10

Results Overview

Number of participants that experienced response/total number of participants per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Response was defined as Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), a 30% or greater decrease in the sum of the longest diameter of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 18 weeks for individual; Up to 40 months for cohort

Results posted on

2017-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment. Gemcitabine: 800 mg IV day 1 and 8 Doxil: 24 mg/m2 every 21 days IV
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) n=5 Participants Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment. Gemcitabine: 800 mg IV day 1 and 8 Doxil: 24 mg/m2 every 21 days IV
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks for individual; Up to 40 months for cohort

Outcome measures

Outcome measures
Measure	Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) n=5 Participants Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment. Gemcitabine: 800 mg IV day 1 and 8 Doxil: 24 mg/m2 every 21 days IV
Response Rate	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 40 months

Population: Due to lack of follow-up, objective could not be determined.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) n=5 Participants Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment. Gemcitabine: 800 mg IV day 1 and 8 Doxil: 24 mg/m2 every 21 days IV
Time to Progression	NA participants Median time to progression was not reached due to lack of events; insufficient number of participants with events.

Adverse Events

Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV) n=5 participants at risk Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment. Gemcitabine: 800 mg IV day 1 and 8 Doxil: 24 mg/m2 every 21 days IV
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	20.0% 1/5
Blood and lymphatic system disorders Hemoglobin	80.0% 4/5
Investigations Leukocytes (total WBC)	40.0% 2/5
Investigations Neutrophils/granulocytes (ANC/AGC)	40.0% 2/5
Investigations Platelets	40.0% 2/5
General disorders Fatigue (asthenia, lethargy, malaise)	80.0% 4/5
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	40.0% 2/5
General disorders Rigors/chills	40.0% 2/5
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	20.0% 1/5
General disorders Injection site reaction/extravasation changes	20.0% 1/5
Skin and subcutaneous tissue disorders Rash/desquamation	40.0% 2/5
Metabolism and nutrition disorders Anorexia	40.0% 2/5
Gastrointestinal disorders Constipation	40.0% 2/5
Gastrointestinal disorders Diarrhea	40.0% 2/5
Gastrointestinal disorders Heartburn/dyspepsia	20.0% 1/5
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), Oral cavity	80.0% 4/5
Gastrointestinal disorders Nausea	80.0% 4/5
Gastrointestinal disorders Taste alteration (dysgeusia)	20.0% 1/5
Gastrointestinal disorders Vomiting	20.0% 1/5
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus	20.0% 1/5
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS	20.0% 1/5
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS	40.0% 2/5
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	20.0% 1/5
Investigations Creatinine	20.0% 1/5
Metabolism and nutrition disorders Metabolic/Laboratory - Other	20.0% 1/5
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized	20.0% 1/5
Musculoskeletal and connective tissue disorders Muscular/skeletal hypoplasia	20.0% 1/5
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	20.0% 1/5
Nervous system disorders Dizziness	20.0% 1/5
Nervous system disorders Neurology - Other	40.0% 2/5
Musculoskeletal and connective tissue disorders Pain, Back	60.0% 3/5
Musculoskeletal and connective tissue disorders Pain, Joint	20.0% 1/5
Hepatobiliary disorders Pain, Liver	20.0% 1/5
Musculoskeletal and connective tissue disorders Pain, Muscle	20.0% 1/5
Respiratory, thoracic and mediastinal disorders Pain, Throat/pharynx/larynx	20.0% 1/5
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	20.0% 1/5

Additional Information

Leonard Appleman, MD, PhD

University of Pittsburgh

Phone: 412-648-6538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place