NCT00470366 · REGISTRY CONDITION SEARCH

Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

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: 2017-11-28

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.

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

Rate of Complete Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Percentage of Participants With Progression Free Survival

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outcome · POSTED

Number of Patients With Treatment Related Toxicity

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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: DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor meeting 1 of the following criteria: * Poor risk, defined by any of the following: * Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following: * Pretreatment serum lactate dehydrogenase (LDH) \> 10 times upper limit of normal (ULN) * Pretreatment serum human chorionic gonadotropin (HCG) \> 50,000 IU/L * Pretreatment serum alpha fetoprotein (AFP) \> 10,000 ng/mL * Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values): * Bone metastases * Brain metastases * Hepatic metastases * Any nonpulmonary metastases (i.e., skin, spleen) * Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases * Modified intermediate risk, defined by any of the following: * Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values: * Pretreatment serum LDH 3.0-10 times ULN * Pretreatment serum HCG 5,000-50,000 IU/L * Pretreatment serum AFP 1,000-10,000 ng/mL * Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site): * Bone metastases * Brain metastases * Hepatic metastases * Any nonpulmonary visceral metastases (i.e., skin, spleen) * Previously untreated disease * Measurable or evaluable disease PATIENT CHARACTERISTICS: * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine normal or creatinine clearance \> 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters) * AST and ALT ≤ 3 times ULN * Bilirubin ≤ 2.0 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent malignancy except for nonmelanoma skin cancer * No known HIV positivity * No active infections PRIOR CONCURRENT THERAPY: * Recovered from prior surgery * More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented) * No prior chemotherapy * No other concurrent cytotoxic therapy * Concurrent radiotherapy and surgery allowed for treatment of brain metastases
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
intervention Names
Biological: pegfilgrastim
Drug: cisplatin
Drug: ifosfamide
Drug: paclitaxel
label
Paclitaxel, Ifosfamide, and Cisplatin
type
EXPERIMENTAL

interventions

arm Group Labels
Paclitaxel, Ifosfamide, and Cisplatin
name
pegfilgrastim
type
BIOLOGICAL
arm Group Labels
Paclitaxel, Ifosfamide, and Cisplatin
name
cisplatin
type
DRUG
arm Group Labels
Paclitaxel, Ifosfamide, and Cisplatin
name
ifosfamide
type
DRUG
arm Group Labels
Paclitaxel, Ifosfamide, and Cisplatin
name
paclitaxel
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 60
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
measure
Rate of Complete Response
time Frame
3 years

secondary Outcomes

description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
measure
Progression-free Survival
time Frame
Up to 8 years
description
Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
measure
Percentage of Participants With Progression Free Survival
time Frame
3 years
description
Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0
measure
Number of Patients With Treatment Related Toxicity
time Frame
3 years

Full study description

brief Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.
detailed Description: OBJECTIVES: * Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors. * Determine the safety of this regimen in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery. After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Source references