Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors (NCT00058253) | Clinical Trial Compass
CompletedPhase 1
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
United States80 participantsStarted 2003-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 …
What they're measuring
1
Maximum tolerated dose determined by dose-limiting toxicities assessed using the NCI Common Toxicity Criteria (CTC) version 2.0