| Exclusion Criteria: | 1) Patients with T1, N0 and inoperable T4 (unequivocal organ involvement). Inoperable T4 lesions are permitted in the Phase 1 portion of the study but not Phase 2.
2) Patients with distant metastasis, including M1b lymph node status (M1b status allowed on Phase I only for patients appropriate for chemoradiation). Lymph nodes suspicious of M1b status by CT scan must be verified by fine-needle aspiration cytology.(Phase 2 only)
3) Patients with a TE fistula or direct invasion into the mucosa of the trachea or major bronchi. Bronchoscopy (with biopsy and cytology if lesion is seen) is required, to exclude TE fistula if the primary carcinoma is <26 cm from the incisors. Bronchoscopy is also required when the cancer is at or above the carina by an imaging study.
4) For Phase 2: Patients with positive pleural, pericardial, or peritoneal cytology.
5) For Phase 2: Patients with carcinoma of the cervical esophagus.
6) For Phase 2: Patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes.
7) For Phase 2: Patients with multiple primary carcinomas of the esophagus.
8) Prior chemotherapy, surgery or radiotherapy for esophageal or gastroesophageal junction cancer. Phase I patients with prior chemotherapy are permitted to enter.
9) Prior radiotherapy that would overlap the anticipated study treatment fields or radiotherapy to =/>30% of the marrow cavity (no prior chest irradiation).
10) Patients with symptomatic hypercalcemia or hypercalcemia that is >Grade 2.
11) Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
12) Pregnant or nursing females. Fertile patients (male and female) must use effective contraception during and for one month after completion of study treatment as follows: A) Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of therapy until 30 days after the final dose of therapy; or
13) (Continuation of #12) B) Consistent and correct use of one of the following acceptable methods of birth control: a) Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; or b) Implants of levonorgestrel; c) Injectable progestogen; d) Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; or e) Oral or patch contraceptives (either combined or Progestogen only), f) Barrier methods including diaphragm or condom with a spermicide.
14) Active secondary malignancy or history of other malignancy within the last 5 years (patients who have been disease-free for 5 years, or have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma of the cervix are eligible). An 'active' malignancy is one for which treatment is ongoing or there is clinical or radiological evidence of tumor. Patients with a recent history of prostate cancer (i.e., less than 5 years) are permitted to enroll into the Phase I portion of the study.
15) Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
16) Concurrent treatment with an investigational agent or device within 28 days prior to the first dose of therapy or participation in another clinical investigation.
17) Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or tumor embolization) except for study treatment including: docetaxel, 5-FU, and radiation therapy.
18) Known hypersensitivity to gossypol, its enantiomers, or its excipients.
19) Known hypersensitivity to docetaxel, 5-FU or their excipients.
20) Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. |