Trial Outcomes & Findings for Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma (NCT NCT00183820)
NCT ID: NCT00183820
Last Updated: 2026-07-01
Results Overview
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
Results posted on
2026-07-01
Participant Flow
Recruitment for this study opened in November 2004 and closed in June 2012. All subjects were seen and treated in the medical clinics at the University of Southern California and Los Angeles General Medical Center.
Participant milestones
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Alternative therapy received
|
4
|
|
Overall Study
non-compliance
|
2
|
Baseline Characteristics
Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=30 Participants
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Age, Continuous
|
32.4 Years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 yearsPopulation: 1 patient was inevaluable.
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=29 Participants
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Tumor Response
Complete Response (CR)
|
2 Participants
|
|
Tumor Response
Partial Response (PR)
|
7 Participants
|
|
Tumor Response
Stable Disease (SD)
|
15 Participants
|
|
Tumor Response
Progressive Disease (PD)
|
5 Participants
|
SECONDARY outcome
Timeframe: Through study completion, about 9 yearsProgression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
Outcome measures
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=30 Participants
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Progression-Free Survival
|
6.5 Months
Interval 3.2 to 27.5
|
SECONDARY outcome
Timeframe: Through study completion, about 9 yearsMeasuring Overall Survival
Outcome measures
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=30 Participants
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Overall Survival
|
18.3 Months
Interval 12.0 to 71.8
|
Adverse Events
Paclitaxel, Gemcitabine, and Oxaliplatin
Serious events: 29 serious events
Other events: 29 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=30 participants at risk
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Investigations
Alkaline phosphatase
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
General disorders
Death not associated with CTCAE term (Death NOS)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Investigations
ALT (SGPT)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Investigations
AST (SGOT)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Blood and lymphatic system disorders
Platelets
|
20.0%
6/30 • Number of events 6 • about 9 years
|
|
General disorders
Allergic reaction/hypersensitivity (including drug fever)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
16.7%
5/30 • Number of events 5 • about 9 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
43.3%
13/30 • Number of events 13 • about 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-lower)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Nervous system disorders
Ataxia (incoordination)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Ear and labyrinth disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Nervous system disorders
Neuropathy: sensory
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.7%
2/30 • Number of events 2 • about 9 years
|
Other adverse events
| Measure |
Paclitaxel, Gemcitabine, and Oxaliplatin
n=30 participants at risk
paclitaxel, gemcitabine, and oxaliplatin:
1. Paclitaxel 170 mg/m2 IV d 1 14 days
2. Gemcitabine 800 mg/m2 IV d 1 14 days
3. Oxaliplatin 100 mg/m2 IV d 1 14 days
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Blood and lymphatic system disorders
Platelets
|
50.0%
15/30 • Number of events 15 • about 9 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
83.3%
25/30 • Number of events 25 • about 9 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
General disorders
Rigors/chills
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
General disorders
Weight loss
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Blood and lymphatic system disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Vascular disorders
Flushing
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
96.7%
29/30 • Number of events 29 • about 9 years
|
|
Injury, poisoning and procedural complications
Injection site reaction/extravasation changes
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
30.0%
9/30 • Number of events 9 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
46.7%
14/30 • Number of events 14 • about 9 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Gastrointestinal disorders
Anorexia
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Gastrointestinal disorders
Diarrhea
|
56.7%
17/30 • Number of events 17 • about 9 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral cavity)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) (Oral cavity)
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Gastrointestinal disorders
Nausea
|
70.0%
21/30 • Number of events 21 • about 9 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
76.7%
23/30 • Number of events 23 • about 9 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
15/30 • Number of events 15 • about 9 years
|
|
General disorders
Allergic reaction/hypersensitivity (including drug fever)
|
30.0%
9/30 • Number of events 9 • about 9 years
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
20.0%
6/30 • Number of events 6 • about 9 years
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Ear and labyrinth disorders
Tinnitus
|
40.0%
12/30 • Number of events 12 • about 9 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
90.0%
27/30 • Number of events 27 • about 9 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
23.3%
7/30 • Number of events 7 • about 9 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Infections and infestations
Infection - Other (Specify, __)
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Dental-tooth)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Joint)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Rectum)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
General disorders
Edema:limb
|
23.3%
7/30 • Number of events 7 • about 9 years
|
|
Investigations
ALT (SGPT)
|
66.7%
20/30 • Number of events 20 • about 9 years
|
|
Investigations
AST (SGOT)
|
60.0%
18/30 • Number of events 18 • about 9 years
|
|
Gastrointestinal disorders
Albumin, serum-low (hypoalbuminemia)
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Investigations
Alkaline phosphatase
|
56.7%
17/30 • Number of events 17 • about 9 years
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Metabolism and nutrition disorders
Creatinine
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
46.7%
14/30 • Number of events 14 • about 9 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
13.3%
4/30 • Number of events 4 • about 9 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
20.0%
6/30 • Number of events 6 • about 9 years
|
|
Nervous system disorders
Ataxia (incoordination)
|
16.7%
5/30 • Number of events 5 • about 9 years
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • Number of events 7 • about 9 years
|
|
Psychiatric disorders
Mood alteration (Anxiety)
|
20.0%
6/30 • Number of events 6 • about 9 years
|
|
Psychiatric disorders
Mood alteration (Depression)
|
26.7%
8/30 • Number of events 8 • about 9 years
|
|
Nervous system disorders
Neuropathy: motor
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Nervous system disorders
Neuropathy: sensory
|
80.0%
24/30 • Number of events 24 • about 9 years
|
|
Eye disorders
Vision-blurred vision
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Gastrointestinal disorders
Pain (Dental/teeth/peridontal)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Nervous system disorders
Pain (Head/headache)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
36.7%
11/30 • Number of events 11 • about 9 years
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
46.7%
14/30 • Number of events 14 • about 9 years
|
|
General disorders
Pain - Other (Specify, __)
|
10.0%
3/30 • Number of events 3 • about 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2 • about 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
10/30 • Number of events 10 • about 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.3%
1/30 • Number of events 1 • about 9 years
|
|
General disorders
Flu-like syndrome
|
3.3%
1/30 • Number of events 1 • about 9 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place