The Effect of Docetaxel or Gemcitabine-based Chemotherapy in East Asian and Caucasian Patients

NCT00695994 | Completed Phase 2

• 1 other identifier: CTRG-PG02/26/06
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

1. 1.to compare the toxicity profile and efficacy of gemcitabine/carboplatin or docetaxel in East Asian and Caucasian patients.
2. 2.to determine the genotype distribution of genes involved in docetaxel and gemcitabine pathways in East Asian and Caucasian patients.
3. 3.to evaluate the association between genotypes and
4. 4.treatment toxicity
5. 5.treatment efficacy
6. 6.pharmacokinetics.

Conditions

Non Small Cell Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Treatment toxicities

  Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]

  36 weeks

Secondary Outcomes (1)

• objective tumour response, survival, median time to progression, and duration of response

  36 weeks

Study Arms (2)

Docetaxel

EXPERIMENTAL

Docetaxel will be administered at a dose of 75 mg/m2 given as a 1-hour intravenous infusion on day 1 of a 21-day cycle.

Drug: Docetaxel

Gemcitabine and carboplatin

EXPERIMENTAL

Carboplatin will be administered as a 1-hour infusion on day 1 of a 21-day cycle. Gemcitabine will be administered as a 30-minute infusion at the dose of 1000 mg/m2 in 250 mL over 30 minutes, on day 1 and 8 of a 21-day cycle. It will be given after carboplatin infusion.

Drug: gemcitabine and carboplatin

Interventions

Docetaxel DRUG

Docetaxel will be administered at a dose of 75 mg/m2 given as a 1-hour intravenous infusion on day 1 of a 21-day cycle. Docetaxel is re-constituted in 500 mL of normal saline and infused through a peripheral or central venous line. Docetaxel (Taxotere®, Sanofi-Aventis Inc.) is available in 80 mg and 20 mg in 2 mL polysorbate 80, 13% (w/w) ethanol in Water for Injection.

Also known as: Docetaxel (Taxotere®, Sanofi-Aventis Inc.)

Docetaxel

gemcitabine and carboplatin DRUG

Gemcitabine (Gemzar®, Lily Inc.) is available in vials containing 1000 mg or 200 mg of active drug formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Carboplatin (Spectrum Pharmaceuticals, Inc.) is supplied as a 10 mg/mL aqueous solution. Unopened vials of gemcitabine are stable when stored at controlled room temperature at 25°C, protected from bright light. It can be diluted in normal saline or 5% dextrose. The solution remains stable for 8 hours at 25°C after reconstitution. Carboplatin will be administered as a 1-hour infusion on day 1 of a 21-day cycle. It will be given before gemcitabine at the dose to achieve an AUC of 5 using the Calvert formula. Gemcitabine will be administered as a 30-minute infusion at the dose of 1000 mg/m2 in 250 mL over 30 minutes, on day 1 and 8 of a 21-day cycle. It will be given after carboplatin infusion.

Also known as: Gemcitabine (Gemzar®, Lily Inc.), Carboplatin (Spectrum Pharmaceuticals, Inc.)

Gemcitabine and carboplatin

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed i) AJCC/UICC stage IIIB or IV non small cell lung cancer and stage IV breast cancer for which docetaxel is indicated. ii) AJCC/UICC stage IIIB or stage IV non small cell lung cancer for which gemcitabine/carboplatin is indicated.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>=20 mm with conventional techniques or as \>=10 mm with spiral CT scan. See section 11.2 for the evaluation of measurable disease.
• Eligible patients must not have been on previous anticancer therapy including chemotherapy, radiotherapy, biological therapy, or investigational therapy for at least 4 weeks before study entry (6 weeks if prior therapy included nitrosoureas or mitomycin C). Prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non- metastatic disease, is allowed if the last dose last dose was given 6 months or more before study entry.
• Patients eligible for docetaxel should have received at least one prior line of palliative chemotherapy. Patients eligible for gemcitabine/carboplatin should not have prior palliative therapies.
• Age \>=18 years.
• Life expectancy of greater than 8 weeks.
• ECOG performance status \<=2 (Karnofsky \>=60%).
• Patients must have normal organ and marrow function as defined below:
• leukocytes \>=3,000/mcL
• absolute neutrophil count \>=1,500/mcL
• platelets \>=100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) \<=2.5 X institutional upper limit of normal
• creatinine within normal institutional limits OR
• creatinine clearance \>=60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients should not be receiving any other investigational agents.
• Patients with rapidly progressing brain metastases should be excluded from this clinical trial because of their poor prognosis. Furthermore they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or gemcitabine.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because docetaxel and gemcitabine are embryotoxic/fetotoxic with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with docetaxel or gemcitabine, breastfeeding should be discontinued if the mother is treated with docetaxel or gemcitabine. These potential risks may also apply to other agents used in this study.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (1)

• Limviphuvadh V, Tan CS, Konishi F, Jenjaroenpun P, Xiang JS, Kremenska Y, Mu YS, Syn N, Lee SC, Soo RA, Eisenhaber F, Maurer-Stroh S, Yong WP. Discovering novel SNPs that are correlated with patient outcome in a Singaporean cancer patient cohort treated with gemcitabine-based chemotherapy. BMC Cancer. 2018 May 11;18(1):555. doi: 10.1186/s12885-018-4471-x.

  PMID: 29751792 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Interventions

Docetaxel; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes

Study Officials

• Wei Peng Yong, MRCP, MB ChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ross Soo

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: October 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

SG (1)