NCT00183820 · REGISTRY CONDITION SEARCH

Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-07-01

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response

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outcome · POSTED

Progression-Free Survival

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 16 Years
sex: MALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: paclitaxel, gemcitabine, and oxaliplatin
label
paclitaxel, gemcitabine, and oxaliplatin
type
EXPERIMENTAL

interventions

arm Group Labels
paclitaxel, gemcitabine, and oxaliplatin
description
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
name
paclitaxel, gemcitabine, and oxaliplatin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Tumor Response
time Frame
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

secondary Outcomes

description
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
measure
Progression-Free Survival
time Frame
Through study completion, about 9 years
description
Measuring Overall Survival
measure
Overall Survival
time Frame
Through study completion, about 9 years

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-cc6f3443c438012a311d
requested nct id
NCT00183820
primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
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id
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nct id
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occurrences
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exact text
NCT00183820
start
0
offset unit
unicode_code_points
query cond
Testicular Cancer
query disease state id
ds-testicular-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
source file sha256
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice