Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer

NCT01038752 | Terminated Phase 2 Results DMC

• 1 other identifier: Optimum-Suramin-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; suramin; lung cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria

  Insufficient data

  Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.

Secondary Outcomes (7)

• Overall Survival of Participants

  First treatment date to date of death

• Overall Response Rate (Complete Response + Partial Response) of Participants

  Tumor assessment at every other cycle

• Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.

  Day 1 of each cycle; end of treatment visit; at follow-up.

• Pre-treatment bFGF Levels Correlation With Survival.

  Before first treatment

• Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes

  Randomization date

Study Arms (2)

Suramin

EXPERIMENTAL

This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.

Drug: Suramin Drug:Docetaxel Drug: Carboplatin

Standard of care

PLACEBO COMPARATOR

This group will receive placebo with docetaxel and carboplatin.

Drug: Placebo Drug: Docetaxel Drug: Carboplatin

Interventions

Suramin Drug:Docetaxel Drug: Carboplatin DRUG

Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).

Also known as: CI-1003, PD 002927-0015F, NSC 34936, Bayer 205, Germanin, Metaret, Taxotere, Paraplatin

Suramin

Placebo Drug: Docetaxel Drug: Carboplatin DRUG

Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).

Also known as: Taxotere, Paraplatin

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
• Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
• Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
• Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
• Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
• Lesions that are not considered measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Tumor lesions situated in a previously irradiated area
• ECOG performance status of 0-1.
• Life expectancy ≥ 3 months.

You may not qualify if:

• History of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
• Grade 3 or 4 neuropathy.
• Women who are pregnant or breast-feeding.
• Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including neoadjuvant or adjuvant chemotherapy.
• Currently active second malignancy other than non-melanoma skin cancer. Currently active malignancy does not include prior malignancy treated with therapy and considered to have less than 30% risk of relapse.

Sponsors & Collaborators

• Optimum Therapeutics, LLC: lead

Study Sites (2)

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Suramin; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Limitations and Caveats

The study was terminated prematurely due to the loss of follow-up of 6 of 14 participants before progression and slow accrual. Due to the resulting small numbers, no analysis was attempted.

Results Point of Contact

• Title: Dr. M. Guillaume Wientjes
• Organization: Optimum Therapeutics

gwientjes@optimumtx.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: August 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 21, 2015
• Results First Posted: October 21, 2014

Record last verified: 2015-05

Locations

US (2)