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Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.

Phase 1
18 Years
Open (Enrolling)
Extensive Stage Small Cell Lung Cancer, Hereditary Paraganglioma, Male Breast Cancer, Malignant Paraganglioma, Metastatic Gastrointestinal Carcinoid Tumor, Metastatic Pheochromocytoma, Pancreatic Polypeptide Tumor, Recurrent Breast Cancer, Recurrent Cervical Cancer, Recurrent Endometrial Carcinoma, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Recurrent Neuroendocrine Carcinoma of the Skin, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pheochromocytoma, Recurrent Prostate Cancer, Recurrent Renal Cell Cancer, Recurrent Small Cell Lung Cancer, Recurrent Uterine Sarcoma, Regional Gastrointestinal Carcinoid Tumor, Regional Pheochromocytoma, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage III Neuroendocrine Carcinoma of the Skin, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Prostate Cancer, Stage III Renal Cell Cancer, Stage III Uterine Sarcoma, Stage IIIA Breast Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Endometrial Carcinoma, Stage IV Neuroendocrine Carcinoma of the Skin, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Prostate Cancer, Stage IV Renal Cell Cancer, Stage IV Uterine Sarcoma, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer, Thyroid Gland Medullary Carcinoma

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Trial Information

Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.


I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and
vinorelbine in advanced solid tumors.

II. To obtain preliminary information regarding the activity of this combination.


I. To evaluate the safety and tolerability of this combination.


Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine
ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Inclusion Criteria


- Patients with histologically confirmed metastatic or unresectable solid tumors for
which standard curative measures do not exist or are no longer effective; histology
will be limited to those tumors for which temsirolimus or vinorelbine have reported
clinical activity: lung, breast, ovary, cervix, prostate, uterus, renal, bladder and
neuroendocrine tumors

- SWOG performance status of 0-2

- Projected life expectancy of at least 3 months

- Provision of informed consent prior to any study-related procedures

- Negative pregnancy test for women of childbearing potential

- Female patients must not be pregnant due to the potential mutagenicity and
teratogenicity of this treatment; a pregnancy test must be administered 7 days prior
to administration of therapy to women of childbearing potential; patients must agree
to use some form of contraception while on this study at initiation and for the
duration of participation in the study; sexually active males must also use a
reliable and appropriate method of contraception; post-menopausal women must be
amenorrheic for at least 12 months to be considered of nonchildbearing potential

- Patients must have recovered from acute toxicities from previous surgery,
chemotherapy or radiation therapy

- ANC >= 1500/mm^3

- Platelet count >= 100,000 cells/mm^3

- Hemoglobin >= 9.0g/dL

- Serum creatinine =< 1.5 mg/dl

- Hepatic function: Patients must have adequate liver functions: AST or ALT =< 2.5 X
upper limit of normal (ULN), alkaline phosphatase =< 2.5 X upper limit of normal; in
patients with bone metastasis and no evidence of liver metastasis and bilirubin =<
upper limit of normal an alkaline phosphatase =< 5 ULN will be allowed

- Serum Bilirubin =< 1.0 mg/dL

- Peripheral neuropathy grade 0-1

- No other concomitant therapy directed at the cancer is allowed


- Prior therapy with vinorelbine or an mTor inhibitor

- Receipt of any investigational agents within 30 days prior to commencing study

- Last dose of prior chemotherapy discontinued less than 4 weeks before the start of
study therapy

- Last radiation therapy within the last 4 weeks before the start of study therapy,
except palliative radiotherapy

- Any unresolved toxicity greater than CTC grade 1 from previous anticancer therapy,
excluding alopecia

- CTC Grade 1 or greater neuropathy (motor or sensory) at study entry

- Hematologic function with absolute neutrophils =< 1500/mm^3 and/or platelets <

- Hepatic function with serum bilirubin greater than the upper institutional limits of
normal, ALT and AST > 2.5 times the upper institutional limits of normal

- Concurrent use of strong inhibitors of CYP3A4: ketoconazole, itraconazole, ritonavir,
amprenavir, indinavir, nelfinavir, delavirdine and voriconazole

- CYP3A4 inducers should be avoided or used with caution; the use of these agents is
discouraged: rifabutin, rifampicin, rifapentine, carbamazepine, Phenobarbital,
phenytoin and St. John's wart

- Ongoing long term use of steroids for chronic conditions

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of Temsirolimus and Vinorelbine

Outcome Time Frame:

1 month up to 18 months

Safety Issue:


Principal Investigator

Agustin Garcia

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

January 2014

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Hereditary Paraganglioma
  • Male Breast Cancer
  • Malignant Paraganglioma
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Metastatic Pheochromocytoma
  • Pancreatic Polypeptide Tumor
  • Recurrent Breast Cancer
  • Recurrent Cervical Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Recurrent Islet Cell Carcinoma
  • Recurrent Neuroendocrine Carcinoma of the Skin
  • Recurrent Non-Small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pheochromocytoma
  • Recurrent Prostate Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Small Cell Lung Cancer
  • Recurrent Uterine Sarcoma
  • Regional Gastrointestinal Carcinoid Tumor
  • Regional Pheochromocytoma
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage III Neuroendocrine Carcinoma of the Skin
  • Stage III Ovarian Epithelial Cancer
  • Stage III Ovarian Germ Cell Tumor
  • Stage III Prostate Cancer
  • Stage III Renal Cell Cancer
  • Stage III Uterine Sarcoma
  • Stage IIIA Breast Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Endometrial Carcinoma
  • Stage IV Neuroendocrine Carcinoma of the Skin
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Prostate Cancer
  • Stage IV Renal Cell Cancer
  • Stage IV Uterine Sarcoma
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Thyroid Gland Medullary Carcinoma
  • Breast Neoplasms
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
  • Lung Neoplasms
  • Paraganglioma
  • Pheochromocytoma
  • Prostatic Neoplasms
  • Small Cell Lung Carcinoma
  • Neoplasms, Germ Cell and Embryonal
  • Carcinoma, Medullary
  • Thyroid Neoplasms
  • Carcinoma, Neuroendocrine
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma
  • Breast Neoplasms, Male
  • Germinoma
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell
  • Sarcoma
  • Carcinoma, Islet Cell



USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800