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

• Pharmacokinetics
• Safety

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

• Clinical response
• Impact of tariquidar on technetium Tc 99m sestamibi uptake

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).

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.

• Cervical Cancer
• Fallopian Tube Cancer
• Kidney Cancer
• Lung Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

• Drug: docetaxel
• Drug: tariquidar

• Experimental: Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 8 and 22.
• Experimental: Patients receive docetaxel IV over 1 hour on days 1 and 8 and tariquidar IV over 30 minutes on days 1 and 22.

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