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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of complete response

Outcome Time Frame:

At the completion of therapy

Safety Issue:

No

Principal Investigator

Darren Feldman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

07-044

NCT ID:

NCT00470366

Start Date:

March 2007

Completion Date:

September 2014

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • Testicular Germ Cell Tumor
  • stage II malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and seminoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma
  • testicular embryonal carcinoma and seminoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma
  • testicular seminoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor
  • stage I malignant testicular germ cell tumor
  • adult central nervous system germ cell tumor
  • ovarian choriocarcinoma
  • ovarian dysgerminoma
  • ovarian embryonal carcinoma
  • ovarian yolk sac tumor
  • ovarian immature teratoma
  • ovarian mature teratoma
  • ovarian monodermal and highly specialized teratoma
  • ovarian polyembryoma
  • ovarian mixed germ cell tumor
  • stage IV ovarian germ cell tumor
  • stage IV extragonadal seminoma
  • stage I extragonadal non-seminomatous germ cell tumor
  • stage II extragonadal non-seminomatous germ cell tumor
  • stage III extragonadal non-seminomatous germ cell tumor
  • stage IV extragonadal non-seminomatous germ cell tumor
  • adult teratoma
  • testicular immature teratoma
  • testicular mature teratoma
  • stage IA ovarian germ cell tumor
  • stage IB ovarian germ cell tumor
  • stage IC ovarian germ cell tumor
  • stage IIA ovarian germ cell tumor
  • stage IIB ovarian germ cell tumor
  • stage IIC ovarian germ cell tumor
  • stage IIIA ovarian germ cell tumor
  • stage IIIB ovarian germ cell tumor
  • stage IIIC ovarian germ cell tumor
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Teratoma
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804