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A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer


PRIMARY OBJECTIVES:

I. To assess response (confirmed complete and partial response) of patients with locally
advanced or metastatic papillary histology renal cell cancer treated with OSI-774.

II. To assess the overall survival and 6-month probability of treatment failure of this
group of patients.

III. To evaluate the qualitative and quantitative toxicities of this regimen. IV. To
investigate in a preliminary manner the association of tumor response with tumor expression
of epidermal growth factor receptor and status of von Hippel Lindau gene mutation.

OUTLINE:

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20
months.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed papillary histology
renal cell carcinoma which is metastatic (M1); patients with unresectable primary
tumor (but M0) are also eligible; patients who have undergone a prior nephrectomy
should have histologic confirmation of the metastatic nature of at least one distant
site of disease

- Patients must have available and be willing to submit representative slides for
central pathology review; these must be sent within 28 days of registration; failure
to submit these materials will make the patient ineligible for this study

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension; soft tissue disease that has been
radiated in the 2 months prior to registration is not assessable as measurable
disease; soft tissue disease within a prior radiation field that was radiated greater
than 2 months prior to registration must have progressed to be considered assessable,
and patients also must have measurable disease outside of the irradiated field;
X-rays, scans or physical examinations used for tumor measurement must have been
completed within 28 days prior to registration; X-rays, scans or physical
examinations for non-measurable disease must have been completed within 42 days prior
to registration

- Patients with metastatic disease who have a resectable primary tumor and are deemed a
surgical candidate may have undergone resection and have recovered from surgery; at
least 28 days must have elapsed since surgery and patient must have recovered from
any adverse effects of surgery

- Patients with a history of brain metastases or who currently have treated or
untreated brain metastases are not eligible; patients with clinical evidence of brain
metastases must have a brain CT or MRI negative for metastatic disease within 56 days
prior to registration

- Patients must have available and be willing to submit archived tumor tissue that will
yield sixteen 5 micron unstained slides for molecular correlative studies related to
the EGFR and vHL pathways

- Patients must not have received prior chemotherapy or immunotherapy

- Patients may have received prior radiation therapy, but must have measurable disease
outside the radiation port; at least 21 days must have elapsed since completion of
prior radiation therapy; patients must have recovered from all associated toxicities
at the time of registration

- Patients must have a Zubrod performance status of 0 - 2

- WBC ≥ 3,000/μl obtained within 14 days prior to registration

- ANC ≥ 1,500/μl obtained within 14 days prior to registration

- Platelet count ≥ 100,000/μl obtained within 14 days prior to registration

- Serum bilirubin ≤ 1.5 x institutional upper limits of normal

- Serum transaminase (SGOT or SGPT) must be ≤ 1.5 x the institutional upper limit of
normal unless the liver is involved with the tumor, in which case serum transaminase
(SGOT or SGPT) must be ≤ 5 x the institutional upper limit of normal; these tests
must be obtained within 14 days prior to registration

- Serum creatinine must be ≤ 2 X the institutional upper limit of normal

- Patients with a known history of the following corneal diseases are not eligible: dry
eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy,
Fuch's dystrophy or other active disorders of cornea

- Patients known to be HIV-positive and receiving combination anti-retroviral therapy
are not eligible due to possible pharmacokinetic interactions with OSI-774

- Patients must not have gastrointestinal tract disease resulting in an inability to
take oral medication or a requirement for IV alimentation, prior surgical procedures
affecting absorption, or active peptic ulcer disease; patients must either be able to
swallow and/or receive enteral medications via gastrostomy feeding tube; patients
with intractable nausea or vomiting are not eligible

- Pregnant or nursing women may not participate on this study because OSI-774 is an
epidermal growth factor inhibitor with the potential for teratogenic or abortifacient
effects based on the data suggesting that EGFR expression is important for normal
organ development; there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with OSI-774; women/men of
reproductive potential may not participate unless they have agreed to use an
effective contraceptive method

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- If day 14, 21, 28 or 42 falls on a weekend or holiday, the limit may be extended to
the next working day; in calculating days of tests and measurements, the day a test
or measurement is done is considered to be day 0; therefore, if a test is done on a
Monday, the Monday two weeks later would be considered day 14; this allows for
efficient patient scheduling without exceeding the guidelines

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the data base

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response probability (confirmed complete and partial response)

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Michael Gordon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03059

NCT ID:

NCT00060307

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location

Southwest Oncology GroupSan Antonio, Texas  78245