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Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

Phase 2
18 Years
Not Enrolling
Neoplasms, Germ Cell and Embryonal

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Trial Information

Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

Inclusion Criteria:

- Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal,
seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP
level and/or hCG level (> or =to 100 x ULN) when a biopsy was not available

- Metastatic GCT patients:

- Progression disease defined as > 10% increase in hCG and/or AFP markers (and/or
documented progressive disease [PD]) during a platinum-based chemotherapy or less
than 6 months after the last cycle (in the case of growing non seminomatous tumor,
without increased markers, a histological documentation of malignant tumor was
required, to exclude growing mature teratoma)

- At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen
with high dose chemotherapy and hematopoietic stem cell support was permitted)

- Eastern Cooperative Oncology Group PS (ECOG PS) grade < or =to 2

- At least 1 bidimensionally measurable lesion by imaging (CT scan) of > or =to 20 mm
outside an irradiated area OR significantly increased tumor markers > 2 x ULN (on >
or =to 2 consecutive tests, even in the absence of measurable lesions)

- Age > or =to 18

- Adequate bone marrow reserve

- Neutrophil count > or =to 1500/mm3

- Platelets > or =to 100,000/mm3

- Renal function:Creatinine < 3 x ULN

- Liver function:Transaminases < or =to 2.5 x ULN, total bilirubin < 1.5 x ULN (if
liver metastases, transaminases < or =to 5 x ULN)

- Laboratory values obtained in the week preceding study entry

- Neurosensory < or =to grade 1 NCI CTC

- Signed informed consent obtained prior to all study procedures

Exclusion Criteria:

- Concomitant high-dose steroids (except for antiemetic prophylaxis)

- Pregnancy, breast-feeding or absence of contraception in sexually active patients

- Prior treatment with oxaliplatin or taxanes

- History of second malignancy, except for cured non melanoma skin cancer or excised in
situ cervical carcinoma

- Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases
not requiring corticosteroid treatment were allowed)

- Treatment with another experimental drug or anticancer agent or participation in
another clinical study within 30 days prior to study

- Other serious illness or uncontrolled infection

- Psychological, social or geographical situation preventing regular follow-up

- Primary tumor in brain/central nervous system

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients

Outcome Time Frame:

during the study conduct

Safety Issue:


Principal Investigator

Nathalie Billon

Investigator Role:

Study Director

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

December 2000

Completion Date:

March 2004

Related Keywords:

  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal