Quarfloxin in Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 2, open-label, multicenter, efficacy and safety study of quarfloxin in patients with low or intermediate grade neuroendocrine cancer. The purpose of this study is to evaluate the rate of clinical benefit response to quarfloxin treatment including the reduction in secretory symptoms of flushing and/or diarrhea or the reduction quantifiable hormones or other biochemical tumor markers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

NCT00707473

Locally Advanced Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Nasal Cavity and Paranasal Sinus Poorly Differentiated Carcinoma Sinonasal Undifferentiated Carcinoma +4 more

ACTIVE_NOT_RECRUITING PHASE2

Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

NCT00896181

Stage II Lymphoepithelioma of the Nasopharynx Stage II Squamous Cell Carcinoma of the Nasopharynx Stage III Lymphoepithelioma of the Nasopharynx +3 more

COMPLETED PHASE2

A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer

NCT05557565

Cervical Cancer

UNKNOWN PHASE2

Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer

NCT00055770

Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx +19 more

COMPLETED PHASE1/PHASE2

Carfilzomib for the Treatment of Patients With Advanced Neuroendocrine Cancers

NCT02318784

Neuroendocrine Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuroendocrine Tumors Carcinoid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quarfloxin

Single arm study - open label.

Group Type EXPERIMENTAL

Quarfloxin

Intervention Type DRUG

IV Quarfloxin 240 mg/m2 daily x5 days every 21 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quarfloxin

IV Quarfloxin 240 mg/m2 daily x5 days every 21 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CX-3543

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma including carcinoid and islet cell cancer. Patients with neuroendocrine tumors associated with MEN1 syndrome are eligible.
* Measureable disease by RECIST
* Unresectable or metastatic disease
* Secretory symptoms of diarrhea or flushing or both attributed to their carcinoid tumor and/or quantifiable hormones or other biochemical markers
* Males and females 18 years of age or older.
* Zero to two prior cytotoxic chemotherapy regimens.
* Patients may be receiving concomitant octreotide Sandostatin®
* Patients must have central IV access, or agree to the insertion of a central IV line.
* All previous cancer therapies, radiation, and surgery, must have been discontinued at least 21 days prior to the start of treatment.
* Acceptable liver function
* Acceptable renal function
* Acceptable hematologic status
* ECOG Performance Status ≤1.
* Anticipated survival of at least 6 months.
* Able to maintain a patient diary.
* For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
* Ability to understand the requirements of the study, provide written informed consent and agree to abide by the study restrictions and return to the clinic for required assessments.

Exclusion Criteria

* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid or small cell carcinoma.
* Pregnant or nursing women.
* Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
* Seizures not controlled by anticonvulsant therapy.
* Participation in any investigational drug study within 28 days before quarfloxin administration or currently receiving investigational therapy.
* Patients with a second malignancy requiring active treatment.
* Active symptomatic bacterial, fungal, or viral infection including active HIV or viral hepatitis.
* Prior treatment with quarfloxin.
* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
* Patients who have exhibited allergic reactions to a similar structural compound or formulation.
* Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No