Trial Outcomes & Findings for Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma (NCT NCT00183794)

Last Updated: 2014-05-22

Results Overview

Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= \<30% decrease or \<20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

6 months after enrollment of last participant

Results posted on

2014-05-22

Participant Flow

Participants were recruited from the USC+LAC Women's Hospital and the USC/Norris Cancer Hospital between December 2002 and April 2008.

Participant milestones

Participant milestones
Measure	Gemcitabine and Docetaxel Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine and Docetaxel n=20 Participants Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Age, Continuous Between 43 and 75 years	59 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment of last participant

Population: Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.

Outcome measures

Outcome measures
Measure	Gemcitabine and Docetaxel n=20 Participants Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Tumor Response Type: CR, PR, SD or PD CR	1 Participants Interval 0.087 to 0.49
Tumor Response Type: CR, PR, SD or PD PR	4 Participants
Tumor Response Type: CR, PR, SD or PD SD	9 Participants
Tumor Response Type: CR, PR, SD or PD PD	6 Participants

SECONDARY outcome

Timeframe: 6 months after enrollment of last patient

Population: All participants who receive the first course of treatment are included in the summary of PFS.

Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)

Outcome measures

Outcome measures
Measure	Gemcitabine and Docetaxel n=20 Participants Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Median Time to Progression (Months)	3 Months Interval 1.0 to 23.0

Adverse Events

Gemcitabine and Docetaxel

Serious events: 12 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Docetaxel n=20 participants at risk Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Investigations White Blood Cell Decreased	25.0% 5/20 • Number of events 12
Infections and infestations Wound Infection	5.0% 1/20 • Number of events 1
Investigations Alkaline Phosphatase Increased	5.0% 1/20 • Number of events 1
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Number of events 1
General disorders Fatigue	5.0% 1/20 • Number of events 1
Blood and lymphatic system disorders Febrile Neutropenia	10.0% 2/20 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminemia	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	5.0% 1/20 • Number of events 1
Investigations Neutrophil Count Decreased	55.0% 11/20 • Number of events 29
Investigations Platelet Count Decreased	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	Gemcitabine and Docetaxel n=20 participants at risk Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
Cardiac disorders Palpitations	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 4
Nervous system disorders Peripheral Motor Neuropathy	10.0% 2/20 • Number of events 2
General disorders Fatigue	35.0% 7/20 • Number of events 12
Investigations Creatinine Increased	5.0% 1/20 • Number of events 1
Blood and lymphatic system disorders Anemia	5.0% 1/20 • Number of events 13
Investigations Neutrophil Count Decreased	5.0% 1/20 • Number of events 12
Investigations White Blood Cell Decreased	50.0% 10/20 • Number of events 14
Gastrointestinal disorders Vomiting	10.0% 2/20 • Number of events 2
Gastrointestinal disorders Ascites	5.0% 1/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 5
Nervous system disorders Peripheral Sensory Neuropathy	30.0% 6/20 • Number of events 9
Gastrointestinal disorders Diarrhea	15.0% 3/20 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	10.0% 2/20 • Number of events 3
Skin and subcutaneous tissue disorders Alopecia	25.0% 5/20 • Number of events 5
General disorders Pin	5.0% 1/20 • Number of events 1
Skin and subcutaneous tissue disorders Rash/Acneiform	20.0% 4/20 • Number of events 7
Investigations Platelet Count Decreased	35.0% 7/20 • Number of events 13
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders Hypocalcemia	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders Hypernatremia	5.0% 1/20 • Number of events 1
Investigations Blood Bilirubin Increased	5.0% 1/20 • Number of events 1
Investigations Alkaline Phosphatase	15.0% 3/20 • Number of events 3
Gastrointestinal disorders Constipation	15.0% 3/20 • Number of events 4
Metabolism and nutrition disorders Hyperglycemia	15.0% 3/20 • Number of events 5
General disorders Localized Edema	20.0% 4/20 • Number of events 6
Metabolism and nutrition disorders Hypophosphatemia	5.0% 1/20 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	5.0% 1/20 • Number of events 2
Metabolism and nutrition disorders Hyponatremia	10.0% 2/20 • Number of events 2
Nervous system disorders Dizziness	15.0% 3/20 • Number of events 4
Skin and subcutaneous tissue disorders Skin Disorder - Other (specify: skin tear)	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Abdominal Pain	10.0% 2/20 • Number of events 3
Skin and subcutaneous tissue disorders Nail Discoloration	15.0% 3/20 • Number of events 3
Injury, poisoning and procedural complications Bruising	10.0% 2/20 • Number of events 2
Skin and subcutaneous tissue disorders Purpura	5.0% 1/20 • Number of events 1
General disorders Fever	15.0% 3/20 • Number of events 5
Investigations Weight Gain	5.0% 1/20 • Number of events 2
Investigations Aspartate Aminotrasferase Increased	15.0% 3/20 • Number of events 5
Investigations Alanine Aminotransferase Increased	15.0% 3/20 • Number of events 5
General disorders Chills	15.0% 3/20 • Number of events 4
Renal and urinary disorders Urinary Tract Pain	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Mucosits Oral	10.0% 2/20 • Number of events 4
Eye disorders Watering Eyes	5.0% 1/20 • Number of events 1
Musculoskeletal and connective tissue disorders Back Pain	5.0% 1/20 • Number of events 2
Metabolism and nutrition disorders Anorexia	10.0% 2/20 • Number of events 3
Vascular disorders Hot Flashes	5.0% 1/20 • Number of events 1

Additional Information

Agustin Garcia, MD

USC/Norris Cancer Comprehensive Cancer Center

Phone: 323-865-3900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place