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This study will determine the best doses of docetaxel and lonafarnib when the two anti-cancer agents are used in combination. Patients with tumors for which treatment with docetaxel would be appropriate are eligible. A second part of the study will further examine the effectiveness of the combination treatment in men with prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel plus lonafarnib (single arm) | Experimental | Docetaxel plus lonafarnib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel plus lonafarnib | Drug | Docetaxel: 60-75 mg/m2 Lonafarnib: 150-375 mg PO BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and dose-limiting toxicities | Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity | |
| Rate of prostate-specific antigen (PSA) responses | Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with dose-limiting toxicities | Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity | |
| Plasma lonafarnib concentrations | Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| RECIST-defined radiological response rate | Until disease progression, unacceptable dose delays or reductions, or unacceptable toxicity |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C115354 | lonafarnib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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