Clinical trial · Interventional

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

Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients

NCT00470366CI-TRIAL-00030550completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Teratoma	Teratoma	ONTOLOGY_EXACT	0.90
Testicular Germ Cell Tumor	Testicular Germ Cell Tumor	ONTOLOGY_EXACT	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
ifosfamide	Drug	Ifosfamide	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS
pegfilgrastim	Biological	Pegfilgrastim	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Paclitaxel, Ifosfamide, and Cisplatin
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.
interventionNames
1. Biological: pegfilgrastim
2. Drug: cisplatin
3. Drug: ifosfamide
4. Drug: paclitaxel

Primary outcomes (1)

measure
Rate of Complete Response
timeFrame
3 years
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

Secondary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment