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

NCT00470366 | Completed Phase 2 Results DMC

• 2 other identifiers: 07-044MSKCC-07044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free Survival

  Up to 8 years

• Percentage of Participants With Progression Free Survival

  3 years

• Number of Patients With Treatment Related Toxicity

  3 years

Study Arms (1)

Paclitaxel, Ifosfamide, and Cisplatin

EXPERIMENTAL

-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.

Biological: pegfilgrastim; Drug: cisplatin; Drug: ifosfamide; Drug: paclitaxel

Interventions

pegfilgrastim BIOLOGICAL

Paclitaxel, Ifosfamide, and Cisplatin

cisplatin DRUG

Paclitaxel, Ifosfamide, and Cisplatin

ifosfamide DRUG

Paclitaxel, Ifosfamide, and Cisplatin

paclitaxel DRUG

Paclitaxel, Ifosfamide, and Cisplatin

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Central Nervous System Neoplasms; Ovarian Neoplasms; Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Carcinoma, Embryonal; Seminoma; Endodermal Sinus Tumor; Dysgerminoma

Interventions

pegfilgrastim; Cisplatin; Ifosfamide; Paclitaxel

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Germinoma; Mesonephroma

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Darren Feldman, MD
• Organization: Memorial Sloan Kettering Cancer Center

feldmand@mskcc.org

646-422-4491

Study Officials

• Darren Feldman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert J. Motzer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 28, 2017
• Results First Posted: October 24, 2017

Record last verified: 2016-06

Locations

US (2)