GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors

NCT00074022 | Completed Phase 1

• 4 other identifiers: NCI-2012-02563PMH-PHL-017N01CM17107CDR0000341677
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, or other solid tumors. GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with docetaxel may kill more tumor cells

Conditions

Recurrent Non-small Cell Lung Cancer; Recurrent Prostate Cancer; Stage III Prostate Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Stage IV Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• Number of patients experiencing dose limiting toxicities (DLTs), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 (Phase I)

  Up to day 21

• Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

  The 95% confidence intervals will be provided.

  Up to day 42

Secondary Outcomes (7)

• Stable disease rate

  Up to 6 weeks

• Response duration

  Up to 4 years

• Toxicities of GTI-2040 combined with docetaxel, graded according to the NCI CTC v2.0

  Up to 4 years

• Time to disease progression

  Up to 4 years

• Duration of stable disease

  Up to 6 weeks

Study Arms (1)

Treatment (GTI-2040, docetaxel)

EXPERIMENTAL

Phase I (closed to accrual as of 8/5/2004): Patients receive GTI-2040 IV continuously on days 1-14. Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the MTD is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RP2D is defined as the dose preceding the MTD. Phase II: Patients receive GTI-2040 and docetaxel at the RP2D as in phase I.

Biological: GTI-2040; Drug: docetaxel; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

GTI-2040 BIOLOGICAL

Given IV

Treatment (GTI-2040, docetaxel)

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (GTI-2040, docetaxel)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (GTI-2040, docetaxel)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (GTI-2040, docetaxel)

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 confirmed diagnosis of 1 of the following:
• Solid tumor malignancy (phase I only)\*
• Prostate cancer (phase I only)\*
• Non-small cell lung cancer (phase I and II)\*
• Recurrent, metastatic, locally advanced unresectable, or treatment-refractory disease
• Measurable disease
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Previously irradiated lesions are considered measurable provided they have demonstrated progression before study entry
• No bone-only disease
• Must have measurable disease other than bone lesions
• No stage IIIA or IIIB non-small cell lung cancer without a malignant pleural or pericardial effusion that is eligible for first-line radical combined chemotherapy and radiotherapy
• No known progressive or symptomatic brain metastases
• Asymptomatic brain metastases allowed
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms

Interventions

GTI2040; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Natasha Leighl

  Princess Margaret Hospital Phase 2 Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: October 1, 2003
• Primary Completion: November 1, 2007
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

CA (1)