Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase I Study of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC# 330507) in Combination With Docetaxel in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: tanespimycin
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- Group II
- description
- Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: tanespimycin
- Drug: docetaxel
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
* No requirement for supplementary oxygen therapy or oxygen saturations ≤ 88%
* No clinically significant pulmonary comorbidities that require medication (e.g., severe chronic obstructive pulmonary disease that could predispose patient to pulmonary toxicity)
* QTc ≤ 450 msec for male patients (470 for female patients)
* LVEF \> 40% by echocardiogram or MUGA
* Echocardiogram or MUGA required for patients with any of the following:
* Myocardial infarction \> 1 year ago
* NYHA class I or II CHF
* Atrial fibrillation
* Right or left bundle branch block by EKG
* No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No myocardial infarction within the past year
* No active ischemic heart disease within the past year
* No New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
* No poorly controlled angina
* No uncontrolled dysrhythmia
* No congenital long QT syndrome
* No left bundle branch block
* No other significant cardiac disease
* No prior history of cardiac toxicity after receiving anthracyclines such as doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of severe hypersensitivity reaction to paclitaxel, docetaxel, or polysorbate 80
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No grade 2 or greater symptomatic peripheral neuropathy
* No allergy to eggs or egg products
* No other concurrent uncontrolled illness
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy to sole measurable lesion
* No prior mantle-field radiotherapy
* See Disease Characteristics
* No concurrent surgery for sole measurable lesion
* Recovered from prior therapy
* At least 1 week since prior ketoconazole and recovered
* At least 4 weeks since prior investigational anticancer therapeutic drugs
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent medications that prolong QTc interval
* No concurrent medication used to control arrhythmias
* Calcium blockers and beta blockers allowed
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies (investigational or commercial)
* No concurrent CYP3A4 inhibitors, including any of the following:
* Fluconazole
* Itraconazole
* Ketoconazole
* Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
* Nifedipine
* Verapamil
* Diltiazem
* Cyclosporine
* Grapefruit juice
* No concurrent CYP3A4 inducers, including any of the following:
* Carbamazepine
* Phenobarbital
* Phenytoin
* Rifampin
* No concurrent herbal extracts or tinctures with CYP3A4 inhibitory activity, including any of the following:
* Hydrastis canadensis (goldenseal)
* Hypericum perforatum (St. John's wort)
* Uncaria tomentosa (cat's claw)
* Echinacea angustifolia roots
* Trifolium pratense (wild cherry)
* Matricaria chamomilla (chamomile)
* Glycyrrhiza glabra (licorice)
* Dillapiol
* Hypericin
* Naringenin
* Concurrent CYP3A4 substrates allowedReferences
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