Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Completed · Phase 1
Conditions studied: Recurrent Prostate Cancer, Stage IV Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Key facts
- Study ID
- NCT00058253
- Run by
- National Cancer Institute (NCI)
- People needed
- 80
- Starts
- 2003-02-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2014-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed metastatic or unresectable malignancy for which standard curative or palliative therapy does not exist or is no longer effective
- Progressive disease manifested by the following parameters
- For prostate cancer:
- Must have castrate, metastatic disease defined by disease progression after surgical castration or treatment with a gonadotropin-releasing hormone (GnRH) analog (testosterone level less than 50 ng/mL)
- Patients who have not undergone surgical orchiectomy should continue on medical therapies to maintain castrate levels of testosterone
- Progressive metastatic disease on imaging studies (bone scan, CT scan, or MRI) OR metastatic disease and a rising prostate-specific antigen (PSA)
- Biochemical progression indicated by at least 3 rising PSA values (obtained at least 1 week apart) from a baseline OR 2 rising PSA values (more than 1 month apart), where the percentage increase over the range of values is at least 25%
- Patients who have received an antiandrogen as part of first-line hormonal therapy must have shown progression of disease off of the antiandrogen prior to study enrollment
- For other solid tumors:
- Development of new lesions or an increase in pre-existing lesions by bone scintigraphy, CT scan, MRI, positron emission tomography, or physical examination
- Patients whose sole criterion for progression is an increase in a biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or an increase in symptoms are not eligible
- Patients with metastatic disease must not be progressing to the extent as to require palliative treatment within 4 weeks of study entry
- No active brain metastases
- Performance status - Karnofsky 70-100%
- More than 6 months
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT < 1.5 times ULN
- PT ≤ 1.1 times ULN
- Creatinine no greater than 1.4 mg/dL or within ULN
- Creatinine clearance greater than 55 mL/min
- No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
- No dyspnea ≥ grade 2 at rest on room air
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.