Suspended

Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors

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What is being tested

cisplatin

+ ifosfamide
+ paclitaxel
Drug
Who is being recruted

Extragonadal Germ Cell Tumor

+ Testicular Germ Cell Tumor
From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2004

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 4, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors. PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors. OBJECTIVES: Primary * Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel, ifosfamide, and cisplatin vs vinblastine, ifosfamide, and cisplatin as second-line therapy. Secondary * Compare the progression-free survival of patients treated with these regimens. * Compare the toxicity profiles of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months (yes vs no) and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 2-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-18 OR pegfilgrastim SC once within 24-72 hours after completion of chemotherapy. * Arm II: Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 1-5. Patients also receive G-CSF SC on days 7-18 OR pegfilgrastim as in arm I. In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Official TitleA Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 4, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1 patient to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites: * Seminoma * Testis * Retroperitoneum * Mediastinum * Other extragonadal site * Nonseminoma * Testis * Retroperitoneum * Other extragonadal site * No tumor of the mediastinum * Must have evidence of metastatic disease, including either of the following: * Unidimensionally measurable lesions * At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI * Nonmeasurable lesions, including the following: * Small lesions * Bone lesions * Pleural or pericardial effusions * Ascites * Irradiated lesions, unless progression is documented after radiotherapy * Progressive or recurrent disease meeting at least 1 of the following criteria: * Measurable progressive disease * Biopsy-proven residual disease * Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation * Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*: * Progressive GCT after a partial response to first-line therapy * Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR * Second testicular primary with evidence of metastases after first-line therapy * Relapse after adjuvant chemotherapy NOTE: \*Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal\* (ULN) * AST and ALT ≤ 2.5 times ULN\* NOTE: \*Unless hepatic metastases are present Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Other * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior dose-intensive therapy with stem cell replacement Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior paclitaxel * No prior docetaxel * No prior ifosfamide * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy * Concurrent or sequential radiotherapy to brain metastases allowed * No other concurrent palliative radiotherapy Surgery * See Disease Characteristics * Concurrent surgery for brain metastases allowed Other * Recovered from prior therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Group II
Experimental
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 79 locations
Suspended
Northeast Alabama Regional Medical CenterAnniston, United StatesSee the location
Suspended
Rebecca and John Moores UCSD Cancer CenterLa Jolla, United States
Suspended
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, United States
Suspended
Naval Medical Center - San DiegoSan Diego, United States

Suspended79 Study Centers