Clinical trial · Interventional
Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
A Phase I/II Study of Carboplatin / Paclitaxel / Suramin Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
NCT00006929CI-TRIAL-00010537completedPhase 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)
Phase II trial to study the effectiveness of combining suramin, paclitaxel, and carboplatin in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy use 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 Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (suramin, paclitaxel, carboplatin)
- description
- Patients receive suramin IV over 30 minutes on days 1 and 2. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: suramin
- Drug: carboplatin
- Drug: paclitaxel
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Plasma concentrations of suramin of 10-20 uM (Phase I)
- timeFrame
- Up to 72 hours
- measure
- Objective response rate (complete response [CR] and partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed advanced non-small cell lung cancer
* Stage IIIB not amenable to concurrent chemotherapy or radiotherapy (e.g., pleural effusion or low pulmonary reserve)
* Stage IV
* Measurable disease
* Meets criteria for 1 of the following:
* Chemotherapy naive (phases I and II) (phase I closed to accrual 1/29/02) (phase II \[chemotherapy-naive patients\] closed to accrual 9/1/03)
* Previously treated (phase I) (phase I closed to accrual 1/29/02)
* Received no more than 1 prior chemotherapy regimen
* Chemotherapy refractory, defined as disease progression during or within 3 months after carboplatin/paclitaxel chemotherapy (phase II)
* No known brain or leptomeningeal disease unless previously irradiated, currently not undergoing corticosteroid therapy, and clinically asymptomatic
* Performance status - ECOG 0-2
* At least 12 weeks
* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 9.0 g/dL
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 50 mL/min
* Calcium less than 11.5 mg/dL
* No history of myocardial infarction within the past 6 months
* No history of congestive heart failure requiring therapy
* No history of unstable angina
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active serious infection
* HIV negative
* No concurrent uncontrolled diabetes mellitus
* No known hypersensitivity to Cremophor EL
* No grade 2 or greater neuropathy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No known psychiatric condition that would preclude study compliance
* At least 28 days since prior cytotoxic chemotherapy and recovered
* Prior radiotherapy allowed except to indicator lesionReferences
Publications (0)
Data not yet available
No reference posted for this study.