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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470366
• Other study ID #: 07-044
• Secondary ID: MSKCC-07044
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: October 23, 2017
• Start date: March 2007
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Ovarian Cancer
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• pegfilgrastim

Drug:
• cisplatin

• ifosfamide

• paclitaxel

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	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	Up to 8 years
Secondary	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	3 years
Secondary	Number of Patients With Treatment Related Toxicity	Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0	3 years

External Links

•   Memorial Sloan Kettering Cancer Center