Tariquidar and Docetaxel in Treating Patients With Recurrent or Metastatic Lung, Ovarian, Cervical Cancer, or Kidney Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072202

Purpose

RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Tariquidar may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase II trial is studying how well giving tariquidar together with docetaxel works in treating patients with recurrent or metastatic lung, ovarian, cervical cancer, or kidney cancer (no longer accruing patients with ovarian cancer or lung as of 3/01/06).

Condition	Intervention	Phase
Cervical Cancer Fallopian Tube Cancer Kidney Cancer Lung Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: docetaxel Drug: tariquidar	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Clinical Trial of the P-Glycoprotein Antagonist, Tariquidar (XR9576), in Combination With Docetaxel in Patients With Lung, Ovarian, and Cervical Cancer: Analysis of the Interaction Between Tariquidar and Docetaxel

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Lung Cancer Ovarian Cancer

Drug Information available for: Docetaxel Tariquidar

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: No ]
Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical response [ Designated as safety issue: No ]
Impact of tariquidar on technetium Tc 99m sestamibi uptake [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2003
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I (course 1): Experimental Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 8 and 22.	Drug: docetaxel Given IV Drug: tariquidar Given IV
Arm II (course 1): Experimental Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 1 and 22.	Drug: docetaxel Given IV Drug: tariquidar Given IV

Detailed Description:

OBJECTIVES:

Primary

Determine the pharmacokinetic interaction between docetaxel and tariquidar administered in different regimens in patients with recurrent or metastatic lung, ovarian, cervical cancer, or renal cell carcinoma (no longer accruing patients with ovarian or lung cancer as of 3/01/06).
Determine the safety of these regimens in these patients.

Secondary

Determine the potential clinical activity of this regimen in these patients.
Determine the impact of tariquidar on uptake of technetium Tc 99m sestamibi in these patients.

OUTLINE: This is a partially randomized study.

Course 1: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 8 and 22.
- Arm II: Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 1 and 22.

At least 48 hours before day 22 and again at least 3 hours after the day 22 tariquidar treatment, patients undergo a technetium Tc 99m sestamibi scan.

All subsequent courses: Within 7-14 days after the last tariquidar dose in course 1, all patients receive tariquidar IV over 30 minutes and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed disease including any of the following types:
- Lung, cervical, or ovarian cancer (no longer accruing patients with ovarian or lung cancer as of 3/01/06)
  - Recurrent or metastatic disease
  - Disease for which there is no known standard therapy capable of extending life expectancy
  - Primary papillary carcinoma of the peritoneum or fallopian tube cancer allowed
- Renal cell carcinoma
  - Clear cell, type I and type II papillary, chromophobe, or collecting duct and medullary
  - Must meet any 1 of the following criteria:
    - Received prior interleukin (IL)-2 therapy
    - Evaluated for therapy with IL-2 and deemed to be ineligible
    - Evaluated for therapy with IL-2 and refused treatment
Previously treated with at least 1 standard treatment regimen
Measurable disease by radiography or physical examination
- Assessable disease by CA 125 is allowed for ovarian cancer
No untreated brain metastases or brain metastases locally treated within the past 6 months

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 3 months

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 90,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times normal (3 times normal in patients with Gilbert's disease)
SGPT and SGOT no greater than 2.5 times normal

Renal

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 50 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
HIV negative
No other active malignancy within the past 2 years except squamous cell skin cancer
No poor medical risk due to nonmalignant systemic disease
No active uncontrolled infection
No concurrent serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics

Chemotherapy

At least 4 weeks since prior chemotherapy (more than 6 weeks for mitomycin)

Endocrine therapy

More than 2 weeks since prior hormonal therapy

Radiotherapy

At least 4 weeks since prior radiotherapy

Surgery

Not specified

Other

More than 4 weeks since prior experimental therapy
More than 8 weeks since prior UCN-01
No concurrent administration of any of the following CYP3A4 inhibitors:
- Amiodarone
- Clarithromycin
- Erythromycin
- Fluconazole
- Itraconazole
- Ketoconazole
- Indinavir
- Nelfinavir
- Ritonavir
- Saquinavir
- Delavirdine
- Voriconazole
- Troleandomycin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072202

Locations

United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892-1457
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Susan E. Bates, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NCI - Center for Cancer Research ( Susan Elaine Bates )
Study ID Numbers:	CDR0000339336, NCI-03-C-0284
Study First Received:	November 4, 2003
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00072202 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
recurrent small cell lung cancer
stage IV non-small cell lung cancer
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent cervical cancer
stage IVA cervical cancer

stage IVB cervical cancer
extensive stage small cell lung cancer
peritoneal cavity cancer
fallopian tube cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
stage IV renal cell cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Urologic Neoplasms
Docetaxel
Genital Diseases, Female
Neoplasms by Site
Urologic Diseases
Respiratory Tract Diseases
Lung Neoplasms
Kidney Neoplasms
Therapeutic Uses
Peritoneal Diseases

Kidney Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Pharmacologic Actions
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Carcinoma
Adnexal Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009