Trial Outcomes & Findings for Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma (NCT NCT00068393)

Last Updated: 2023-07-07

Results Overview

Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Results posted on

2023-07-07

Participant Flow

The study was activated on December 9, 2003, accrued its first patient on February 24, 2004, and was closed to accrual on April 19, 2007. A total of 39 patients were registered to the study.

Participant milestones

Participant milestones
Measure	Doxorubicin/Gemcitabine Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Overall Study STARTED	39
Overall Study Eligible and Treated	38
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxorubicin/Gemcitabine Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Overall Study Adverse Event	2
Overall Study Death	3
Overall Study Withdrawal by Subject	3
Overall Study Alternative treatment	1
Overall Study Quality of life worsening	1

Baseline Characteristics

Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxorubicin/Gemcitabine n=38 Participants Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Population: Only eligible and treated patients are included in this analysis.

Outcome measures

Outcome measures
Measure	Doxorubicin/Gemcitabine n=38 Participants Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Response Rate by Solid Tumor Response Criteria (RECIST)	16 Percentage of Participants Interval 7.0 to 29.0

SECONDARY outcome

Timeframe: Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Population: Only eligible and treated patients are included in this analysis.

Overall survival is defined as the time from study entry until death from any cause.

Outcome measures

Outcome measures
Measure	Doxorubicin/Gemcitabine n=38 Participants Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Overall Survival	8.8 Months Interval 6.1 to 11.1

SECONDARY outcome

Timeframe: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Population: Only eligible and treated patients are included in this analysis.

Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

Outcome measures

Outcome measures
Measure	Doxorubicin/Gemcitabine n=38 Participants Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Progression-free Survival	3.5 Months Interval 2.2 to 5.2

Adverse Events

Doxorubicin/Gemcitabine

Serious events: 15 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Doxorubicin/Gemcitabine n=38 participants at risk Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Blood and lymphatic system disorders Anemia	13.2% 5/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Leukopenia	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia	18.4% 7/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Cardiac disorders Atrial fibrillation	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Cardiac disorders Sinus tachycardia	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Cardiac disorders Left ventricular systolic dysfunction	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
General disorders Death - multiorgan failure	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dysphagia	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection w/ Gr0-2 neutropenia, lung	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC peristomal	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC upper airway NOS	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Infections and infestations Infection w/ unknown ANC urinary tract NOS	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Chest wall, pain	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.

Other adverse events

Other adverse events
Measure	Doxorubicin/Gemcitabine n=38 participants at risk Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks. Only eligible and treated patients are included in the analysis.
Blood and lymphatic system disorders Anemia	84.2% 32/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Leukopenia	18.4% 7/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Lymphopenia	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Neutropenia	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Thrombocytopenia	18.4% 7/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Cardiac disorders Left ventricular systolic dysfunction	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	71.1% 27/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
General disorders Fever w/o neutropenia	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Weight loss	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Dry skin	13.2% 5/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Alopecia	57.9% 22/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Nail changes	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	15.8% 6/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	39.5% 15/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	39.5% 15/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Dehydration	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea w/o prior colostomy	18.4% 7/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dry mouth	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dyspepsia	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	21.1% 8/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	57.9% 22/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Taste disturbance	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	23.7% 9/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
General disorders Edema: limb	15.8% 6/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Alkaline phosphatase increased	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations AST increased	21.1% 8/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Bilirubin increased	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Investigations Creatinine increased	42.1% 16/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyponatremia	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Psychiatric disorders Anxiety	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Psychiatric disorders Depression	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Neuropathy-sensory	10.5% 4/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Back, pain	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Nervous system disorders Head/headache	7.9% 3/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Joint, pain	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Muscle, pain	21.1% 8/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 5/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	21.1% 8/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.
Vascular disorders Phlebitis	5.3% 2/38 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment.

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place