Germ Cell Neoplasm, Testicular Cancer
Conditions
Keywords
Testicular, Extra gonadal germ cell neoplasm
Brief summary
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment. This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
Interventions
DRUGpaclitaxel, 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
Sponsors
University of Southern California
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure 2. Must have refractory germ cell neoplasm defined as one or more of the following: * patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP 3. Must have one or more of the following (check all that apply): * unidimensionally measurable doze assessed within 14 days prior to registration, * elevated β-HCG \> 20 mIU assessed within 24-48 hours prior to registration, OR * AFP \> 2 x uln assessed within 5-7 days prior to registration Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz. 4. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration 5. May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects 6. Zubrod PS less than or equal to 2 7. Greater than or equal to 16 years of age 8. AGC greater than or equal to 1.5; platelets greater than or equal to 100,000 9. Total bilirubin \< 2.5 x uln; SGOT and alk phos \< 5 x uln (obtained within 14 days prior to registration) 10. LDH (obtained within 7 days prior to registration) 11. Creatinine \< 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis) 12. Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration) 13. Men of reproductive potential must agree to use effective contraceptive method 14. Signed informed consent (including HIPAA authorization)
Exclusion criteria
1. Prior tx with cytotoxic or experimental agents within 14 days prior to registration 2. Evidence of concurrent infection (T \> 96.8F but \< 101.5F; WBC \< 11.0 unless these values can be ascribed to another tumor-related phenomena) 3. Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | Through study completion, about 9 years | Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death. |
| Overall Survival | Through study completion, about 9 years | Measuring Overall Survival |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Quinn, MD
University of Southern California
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.4 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 30 |
| other Total, other adverse events | 29 / 30 |
| serious Total, serious adverse events | 29 / 30 |
Outcome results
None listed