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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00072215
• Date of registration: 04/11/2003
• Primary sponsor: Cancer and Leukemia Group B
• Public title: Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
• Scientific title: A 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
• Date of first enrolment: April 2004
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00072215
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Robert J. Motzer, MD
• Affiliation: Memorial Sloan-Kettering Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Extragonadal Germ Cell Tumor

Testicular Germ Cell Tumor

Intervention(s)

Drug: cisplatin

Drug: ifosfamide

Drug: paclitaxel

Drug: vinblastine

Primary Outcome(s)

Overall survival [Time Frame: 2 months]

Secondary ID(s)

CALGB-90106

CDR0000339340

U10CA031946

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)