Clinical trial · Interventional
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
NCT00039429CI-TRIAL-00067467completedPhase 2ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| atrasentan hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival at 6 months
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection
* Progressive disease, defined by 1 of the following:
* The appearance of 1 or more new lesions
* At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)
* One of the following disease characteristics:
* Disease manifested solely by bone metastases
* At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 2,000/mm\^3 OR
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin less than 1.5 mg/dL
* AST and/or ALT less than 1.5 times upper limit of normal (ULN)
Renal:
* Creatinine less than 1.5 times ULN
Cardiovascular:
* No history of New York Heart Association class II-IV heart disease
Pulmonary:
* No significant pulmonary disease requiring pulse steroid therapy within the past 3 months
Other:
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No other serious concurrent medical illness that would preclude study participation
* No active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy/immunotherapy and recovered
* No more than 1 prior regimen\* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)
* Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: \*A regimen is considered to be at least 4 weeks of treatment
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* Prior radiotherapy for local control or palliation of painful bony lesion allowed
* No prior radiotherapy to target lesions
* No concurrent radiotherapy for palliation or any other indication
Surgery:
* At least 4 weeks since prior surgery and recovered
* Prior nephrectomy allowed
Other:
* Prior bisphosphonates allowedReferences
Publications (1)
- RESULTManola J, Carducci M, Nair S, et al.: Phase II ECOG trial of atrasentan in advanced renal cell carcinoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-5102, 260s, 2007.