Clinical trial · Interventional
Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
A Pilot Study of Low Dose Suramin as Modulator of Docetaxel and Gemcitabine in Patients With Previously Treated Non-Small Cell Lung Cancer (NSCLC)
- 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 randomized phase I trial is studying the side effects and best dose of suramin when given together with either docetaxel or gemcitabine in treating patients with stage IIIB or stage IV non-small cell lung cancer that is refractory to platinum chemotherapy (such as cisplatin, carboplatin, or oxaliplatin). Drugs used in chemotherapy such as docetaxel and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining suramin with either docetaxel or gemcitabine may reduce resistance to the drugs and 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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive low-dose suramin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
- interventionNames
- Drug: suramin
- Drug: docetaxel
- Other: laboratory biomarker analysis
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive low-dose suramin IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8.
- interventionNames
- Drug: suramin
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer * Stage IIIB\* or IV * Progressive disease after prior platinum-containing regimen (e.g., cisplatin, carboplatin, or oxaliplatin) * No known brain or leptomeningeal disease, unless all of the following are true: * Lesions were previously irradiated * No concurrent corticosteroids * No clinical symptoms * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 2.0 mg/dL * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy * No unstable angina * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active serious infectious process * No grade 2 or greater neuropathy * No uncontrolled diabetes mellitus * No psychiatric disorder that would preclude giving informed consent or interfere with study follow-up * See Disease Characteristics * At least 28 days since prior cytotoxic chemotherapy and recovered * No more than 2 prior chemotherapy regimens * No prior docetaxel * No prior gemcitabine * See Disease Characteristics * See Disease Characteristics * Prior radiotherapy allowed * At least 2 weeks since prior epidermal growth factor receptor therapy * Prior suramin allowed * No concurrent anti-HIV medications for HIV-positive patients
References
Publications (0)
Data not yet available