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A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Status
Active
Cancer Type
Brain Cancer
Germ Cell Tumor
Testicular Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
14 and over, Male
Study Type
Treatment
NCT ID
NCT02375204
Protocol IDs
A031102 (primary)
NCI-2014-01696
1407-GUCG
2014-003930-17
PA031102_A01PAMDREVW01
Study Sponsor
Alliance for Clinical Trials in Oncology

Summary

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet know whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Objectives

PRIMARY OBJECTIVES:

I. To compare the overall survival in patients treated with conventional-dose chemotherapy using the paclitaxel, ifosfamide, and cisplatin (TIP) regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the high-dose carboplatin and etoposide (TI-CE) regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT).

SECONDARY OBJECTIVES:

I. To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus (vs.) initial salvage CDCT with TIP.

II. To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE vs. initial salvage CDCT with TIP.

III. To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT.

IV. To prospectively evaluate the International Prognostic Factors Study Group (IPFSG) scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT.

V. To evaluate the association between tumor marker decline rates of alpha-fetoprotein (AFP) and human chronic gonadotropin (HCG) with overall survival (OS) and PFS.

TERTIARY OBJECTIVES:

I. To compare the quality of life among patients >= 18 years treated with TIP vs. those treated with TI-CE using the European Organization for Research and Treatment of Cancer (EORTC) quality of life instruments (EORTC Quality of Life-Core 30 [QOL-C30] and QLQ-Testicular Cancer 26 [TC26]).

II. To evaluate the association between specific germline polymorphisms and patient outcome to treatment.

III. To evaluate the frequency of aberrations in the RAS, phosphoinositide 3-kinase (PI3K), and tumor protein p53 (p53) pathways among patients with refractory or relapsed GCT entering the study.

IV. To correlate aberrations in the RAS, PI3K, and p53 pathways with patient outcome overall and within each treatment arm.

V. To characterize the range of other genetic aberrations (mutations and copy number gains and losses among 341 cancer-related genes) within relapsed and refractory GCT samples.

VI. To establish a GCT biospecimen bank for future analysis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A (TIP): Patients receive paclitaxel intravenously (IV) over 24 hours on day 1, ifosfamide IV over 30 minutes daily and cisplatin IV over 1-96 hours daily on days 2-5, and pegfilgrastim subcutaneously (SC) on day 6 or 7. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM B (TI-CE): Patients receive paclitaxel IV over 3 hours on day 1, ifosfamide IV over 30 minutes daily on days 1-3, and filgrastim SC daily beginning on day 3 and continuing until adequate cluster of differentiation (CD)34+ cell collection or day 15, whichever occurs first. Treatment repeats every 14-21 days for 2 courses in the absence of unacceptable toxicity. Patients then receive carboplatin IV daily and etoposide IV daily on days 1-3, undergo ASCT on day 5, and receive pegfilgrastim SC beginning on day 5 and continuing until absolute neutrophil count (ANC) recovery. Treatment repeats every 21-28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 9, 12, 15, 18, 24, 36, 48, and 60 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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