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

Primary Purpose

Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, Ifosfamide, and Cisplatin

Arm 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.

Outcomes

Primary Outcome Measures

Rate of Complete Response
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 Outcome Measures

Progression-free Survival
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
Percentage of Participants With Progression Free Survival
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
Number of Patients With Treatment Related Toxicity
Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0

Full Information

First Posted
May 3, 2007
Last Updated
October 23, 2017
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00470366
Brief Title
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
Official Title
Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel, Ifosfamide, and Cisplatin
Arm Type
Experimental
Arm 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 Type
Biological
Intervention Name(s)
pegfilgrastim
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Rate of Complete Response
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
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
Time Frame
Up to 8 years
Title
Percentage of Participants With Progression Free Survival
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
Time Frame
3 years
Title
Number of Patients With Treatment Related Toxicity
Description
Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Feldman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J. Motzer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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