BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

Theradex

Status and phase: Unknown; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: ortataxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00039169

CDR0000069359

BAYER-100386

THERADEX-100386

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.

Full description

OBJECTIVES:

• Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer treated with BAY 59-8862.
• Determine the overall survival in patients treated with this drug.
• Determine the time to progression in patients treated with this drug.
• Determine the duration of response (CR and PR) in patients treated with this drug.
• Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
• Determine the pharmacokinetic profile of this drug in selected patients.

OUTLINE: This is a multicenter study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced renal cell cancer

  • Unresectable, refractory, and/or metastatic

• At least 1 measurable lesion

  • A CNS lesion cannot be the sole target lesion
  • Lesions within a previously irradiated field are not considered measurable

• No metastatic brain or meningeal tumors unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9.0 g/dL

Hepatic:

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
• PT, INR, and PTT less than 1.5 times ULN
• No chronic hepatitis B or C

Renal:

• Creatinine no greater than 2 times ULN

Cardiovascular:

• No clinically evident congestive heart failure
• No serious cardiac arrhythmias
• No prior coronary artery disease or ischemia

Other:

• No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication

• No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)

• No substance abuse or medical, psychological, or social conditions that would preclude study compliance

• No active clinically serious infections

• No other condition that is unstable or would preclude study participation

• No grade 2 or greater pre-existing peripheral neuropathy

• No history of seizure disorder

  • Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 months since prior bone marrow or peripheral blood stem cell transplantation
• No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only)
• At least 4 weeks since prior immunotherapy
• At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
• More than 4 weeks since prior thalidomide or bevacizumab
• No prior anticancer vaccines
• No concurrent prophylactic G-CSF
• Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed
• Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study

Chemotherapy:

• No prior systemic cytotoxic chemotherapy
• No prior oxaliplatin
• No other concurrent anticancer chemotherapy

Endocrine therapy:

• Patients with prior metastatic brain or meningeal tumors:

  • No concurrent acute or tapered steroid therapy
  • Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies

• No hormonal therapy for renal cell cancer

Radiotherapy:

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented

• Concurrent palliative radiotherapy allowed provided:

  • No progressive disease
  • No more than 10% of bone marrow is irradiated
  • Radiation field does not encompass a target lesion

• No other concurrent radiotherapy

Surgery:

• At least 4 weeks since prior surgery
• No prior organ allograft

Other:

• At least 4 weeks since prior investigational drugs
• No other concurrent investigational therapy or approved anticancer therapy
• No concurrent illicit drugs or other substances that would preclude study
• Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT
• Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints
• Concurrent bisphosphonates for prophylaxis or bone metastases allowed