A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
1. Patients with histologic proof of adenocarcinoma of the stomach or gastroesophageal
junction will be eligible.
2. Patients must have either metastatic or unresectable local-regional cancer
3. Patients must have measurable disease, defined as lesions that can be accurately
measured in at least one dimension (longest diameter to be recorded) as greater than
or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm
with spiral CT scan.
4. Patients may not have received prior chemotherapy or immunotherapy regimen except in
the adjuvant therapy that ended at least 6 months prior to registration on this
5. Prior limited radiation therapy is permitted. Prior radiotherapy must not have
included major bone marrow containing areas (pelvis, lumbar spine), or contained the
single evaluable lesion in the radiation field. A recovery period of at least 4 weeks
after completion of radiotherapy is required prior to enrollment. Patients receiving
chemotherapy used as radiosensitizer will not be eligible except if chemoradiotherapy
was administered in the adjuvant setting (see 4.4).
6. Patients must have a life expectancy of at least 12 weeks.
7. Patients must have a performance status of less than or equal to 2 (Zubrod scale) or
greater than or equal to 60% (Karnofsky scale) (see appendix B).
8. Patients must give written informed consent.
9. Acceptable liver, renal, and marrow function
10. Patients must be be at least 18 years old.
11. Patients must have recovered from recent surgery. One week must have elapsed from the
time of a minor surgery and 3 weeks from major surgery.
12. This clinical trial is so designed that no person shall on the grounds of race,
color, gender or national origin be excluded from participation in or be denied the
benefits, or be otherwise subjected to discrimination through or under this study.
1. Patients may receive no other concurrent chemotherapy, immunotherapy, or
2. Patients with brain metastases are not eligible.
3. Patients with NYHA Class III or IV heart disease are not eligible (see Appendix F) as
well as those patients with history of angina, myocardial infarction, or congestive
heart failure within six months.
4. Pregnant or lactating women because paclitaxel and bryostatin-1, like most other
anticancer agents, may be harmful to the developing fetus and nursing newborn or
infant. All women of child-bearing potential must have a negative pregnancy test
prior to entry into the study. All patients of child-bearing potential must be
advised of the importance of avoiding pregnancy and using appropriate methods of
contraception while participating in this investigational trial.
5. Patients with serious intercurrent infections, or nonmalignant medical illnesses that
are uncontrolled or whose control may be jeopardized by the complications of this
therapy, are ineligible.
6. Patients with psychiatric disorders rendering them incapable of complying wiht the
requirements of the protocol are ineligible.
7. Patients with serum calcium greater > 12 mg/dl or symptomatic hypercalcemia under
treatment are ineligible.
8. Patients with only bone metastases.
9. Patients with any concurrent active malignancy other than non-melanoma skin cancers
or carcinoma-in-situ of the cervix. Patients with previous malignancies but without
evidence for greater than or equal to 5 years will be allowed to enter the trial.
10. Patients wit bleeding diathesis or those requiring anticoagulation will be excluded.
11. Patients with only non-measurable disease, defined as all other lesions, including
small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with
spiral CT scan) and truly non-measurable lesions.