RTOG 0517 - "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer"

Treatment Plan    (Supplied Drug:  Zometa)

RANDOMIZATION

Arm 1

Zoledronic acid:  4mg, IV, q month (given indefinitely until DC'd at physician's discretion)

Vitamin D & Calcium supplementation

Arm 2

Zoledronic acid:  4mg, IV, q month (given indefinitely until DC'd at physician's discretion)

Vitamin D & Calcium supplementation

Single dose Sr-89 or Sm-153:  Sr-89 (4 mCi) or Sm-153 (1 mCi/kg) body wt, w/i 6 wks of randomiz

Eligibility

• Histol- or cytol-proven solid tumor malignancy of lung, breast, or prostate.

• Minimum diagnostic workup:

  • H&P w/i 8 wks pre-regist

  • Bone scan w/i 4 wks pre-regist; bone mets must be visible on scan.  MRI, PET, or plain x-ray may only be used to confirm bone scan if equivocal.

  • Dental eval including hx of dental surgery w/i 8 wks pre-regist.  Do not repeat if pt has received prior oral bisphosphonate therapy & had dental eval w/i 8 wks pre-regist.

  • Within 2 wks pre-regist:   WBC >2400 cells/mm3; ANC >1800 cells/mm3; platelets >60,000 cells/mm3; Hgb >8.0g/dl (transfusion permitted); serum creat <3mg/dL; total bili <2.5mg/dL; urine dipstick or serum pregnancy test (if applicable).

• Age >18.

• Zubrod 0-2 (breast or prostate primaries); 0-1 (lung primaries).

• Systemic chemo or hormonal therapy is allowed (see protocol for details).  All pts must complete external beam RT w/i 14 days pre-regist.  If pt has undergone CyberKnife tx, tx must be completed >14 days pre-regist.

• Prior oral bisphosphonates allowed.  Duration of bisphosphonate tx must be documented and all bisphosphonates other than study drug must be DC'd pre-regist.

• Women/Men of reproductive potential must use effective contraception.

• No brain mets &/or spinal cord compression.  NOTE:  Pts w/no evidence of brain disease after tx for brain mets are eligible.

• No painful bone mets unless successfully treated pre-regist & pt has stable pain >2 wks after that tx (response of 1, 2, or 3 on Q4 & Q5 of Brief Pain Inventory).

• No prior tx w/Strontium-89 or Samarium-153 for bone mets.

• No tx >6 mos w/IV bisphosphonates pre-study entry.

• No calcitonin, mithramycin, or gallium nitrate w/i 2 wks pre-regist.

• No uncontrolled CHF, HTN refractory to tx, or symptomatic CAD w/i 6 mos pre-study entry.

• No current, active dental problems w/i 4 wks of regist.

• No dental surgery w/i 6 wks of study entry and while receiving study tx. 

• No AIDS.  However, HIV testing is not required for study entry.

• No pregnant or nursing women.

• PRESTUDY REQUIREMENTS:

  • H&P (w/i 8 wks pre-regist)

  • Bone scan (w/i 4 wks pre-regist)

  • Perf status

  • CBC/diff & ANC*

  • Platelets, Hgb*

  • Serum creat*

  • Total bili*

  • Pregnancy test (if applicable)*

  • Dental eval (w/i 8 wks pre-regist)

  • FACT-G*

  • Brief Pain Inventory*

  • EQ-5D*

  *      Within 2 wks pre-regist

• Signed informed consent.