Clinical trial · Interventional
17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies
NCT00087217CI-TRIAL-00009142completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (tanespimycin, paclitaxel)
- description
- Patients receive 17-AAG IV over 1 hour on days 1\*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: tanespimycin
- Drug: paclitaxel
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Phase 2 recommended doses of tanespimycin
- timeFrame
- 28 days
- description
- Tabulated according to the NCI CTC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid malignancy * Metastatic or unresectable disease * Not amenable to standard curative or palliative therapy * No known brain metastases * Performance status - ECOG 0-2 * More than 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal * Creatinine normal * Creatinine clearance ≥ 60 mL/min * QTc \< 450 msec for male patients (470 msec for female patients) * LVEF \> 40% by MUGA * 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 New York Heart Association class III or IV congestive heart failure * No poorly controlled angina * No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs * No history of congenital long QT syndrome * No active ischemic heart disease within the past year * No left bundle branch block * No other significant cardiac disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation * No prior allergy to eggs * No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel * No peripheral neuropathy \> grade 1 * No concurrent uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No concurrent granulocyte colony-stimulating factors * Prior paclitaxel allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) * More than 4 weeks since prior radiotherapy * No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy) * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent therapeutic-dose warfarin for anticoagulation * No concurrent medications that may prolong QTc interval * No other concurrent investigational agents * No other concurrent anticancer agents or therapies
References
Publications (0)
Data not yet available
No reference posted for this study.