Clinical trial · Interventional
Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
- 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 cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboxyamidotriazole | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma
* Slides reviewed at the NCI Laboratory of Pathology
* Failure on therapy of proven efficacy for the disease
* Prior therapy not required for the following metastatic diseases:
* Melanoma
* Non-small cell lung cancer
* Renal cell carcinoma
* No brain metastases
* Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed
* Measurable or evaluable disease required
* Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR
* Elevated PSA associated with prostate cancer
* Other marker-only disease ineligible
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hematocrit at least 27%
Hepatic:
* Liver function tests no greater than 2 times upper limit of normal
* Bilirubin normal
* PT or PTT no greater than 1.25 times upper limit of normal
* Clotting parameters normal
* No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 45 mL/min
* No kidney obstruction
Cardiovascular:
* No cardiac conduction defect requiring antiarrhythmics
* No evidence of myocardial infarction or other myocardial damage within past 6 months
Other:
* HIV negative
* No concurrent infection
* No guaiac-positive stool test
* No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors)
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
* Recovery from prior therapy required
Biologic therapy:
* At least 4 weeks since prior biologic therapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin)
* No progression on carboxyamidotriazole or paclitaxel
* At least 6 months between treatment and relapse
Endocrine therapy:
* At least 4 weeks since prior hormonal therapy
* No concurrent corticosteroids except as physiologic replacement
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* Not specified
Other:
* At least 1 week since prior therapeutic antibiotics
* Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole)
* No concurrent calcium channel blockersReferences
Publications (1)
- RESULTKohn EC, Reed E, Sarosy GA, Minasian L, Bauer KS, Bostick-Bruton F, Kulpa V, Fuse E, Tompkins A, Noone M, Goldspiel B, Pluda J, Figg WD, Liotta LA. A phase I trial of carboxyamido-triazole and paclitaxel for relapsed solid tumors: potential efficacy of the combination and demonstration of pharmacokinetic interaction. Clin Cancer Res. 2001 Jun;7(6):1600-9. PMID 11410496