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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00470366
First received: May 3, 2007
Last updated: August 14, 2013
Last verified: August 2013

May 3, 2007
August 14, 2013
March 2007
September 2014   (final data collection date for primary outcome measure)
Rate of complete response [ Time Frame: At the completion of therapy ] [ Designated as safety issue: No ]
Rate of complete response
Complete list of historical versions of study NCT00470366 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: At the completion of therapy ] [ Designated as safety issue: No ]
  • Number of courses required to achieve maximal response [ Time Frame: At the completion of therapy ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: At the completion of therapy ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: At the completion of therapy ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: At the completion of therapy ] [ Designated as safety issue: Yes ]
  • Progression-free survival
  • Number of courses required to achieve maximal response
  • Duration of response
  • Safety
  • Toxicity
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • Testicular Germ Cell Tumor
  • Biological: pegfilgrastim
  • Drug: cisplatin
  • Drug: ifosfamide
  • Drug: paclitaxel
Experimental: Paclitaxel, Ifosfamide, and Cisplatin
-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.
Interventions:
  • Biological: pegfilgrastim
  • Drug: cisplatin
  • Drug: ifosfamide
  • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00470366
07-044, MSKCC-07044
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Darren Feldman, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP